FDA Device Recalls in 2012
1,851 recalls found
November 2012
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 26, 2012 to its customers. The letter described the product, problem and actions to be taken. To customers were instructed to review this Medical Device Recall notice and addendum; assure that all users are aware of this notice and addendum; place the addendum in the front of Section 7: Modules (p 7.1) and confirm receipt of this communication by faxing the attached Customer Response Form to the fax number/email address indicated on form. Terumo CVS is issuing a Safety Advisory to alert all Terumo System 1 users of the potential for failure and providing an addendum for the Operator Manual with instruction on how to respond to the failure. If you have any question or concerns contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are Monday-Friday, 8AM - 6PM ET.
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI.
This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere
RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction dated May 30, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consigness were instructed to completely avoid affecting the erroneous behaviour, verify in TomoTherapy Hi-Art that the plans sent to TomoTherapy SharePlan 1.1 only have one single fraction group with a single fraction size,used for all fractions, and do not attempt to import treatment plans having more than one fraction size into the product. To completed avoid affecting the erroneous behaviour the user can either offset the measured curves before importing them into beam commissioning or add the depth offset tothe calibration depth. For further information consigness should contact RaySearch Laboratories AB Quality and Regulatory Affairs at +46 722 366 110 or the Tomo Therapy support at support@tomotherapy.com. North America 1 866 368 4807 Belgium 0800 38783 France 0805 631 565 Germany 0800 000 +541 Italy 800-986 399 Netherlands 0800 0201364 Spain 800 3000049 Switzerland 0800 001927 UK 0868 238 6035 China/Northern 10 800 712 1701 China/Southern 10800 120 1701 Hong Kong 800 967912 Japan 0044 22 132374 Singapore 800 1204683 South Korea 0079 81 4800 7204 All other locations + 1 608 824 2900 or +32 2 40 44 44
Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.
Consignees were sent a Boston Scientific "LATITUDE Medical Records Information" letter dated January 2011. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also included the Rate of Occurrence, Action and Further Information sections.
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole
The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial numbers between 547 and 574 may cause a hardware motion error (ID0x08000501).
The recall notification was initiated on July 6, 2012 with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with attached PCA Response Form to all customers who purchased the UniCel DxC 880i, UniCel DxC 860i, UniCel 680i, UniCel DxC 660i Clinical System Integrated Workstations UCTA Sample Syringe Pump Drive Assembly. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were notified that Beckman Coulter will schedule a Service Call to replace the affected sample syringe pump drive assemblies. Customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any questions regarding the PCA, were instructed to call Customer Support at (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact Beckman Coulter Representative.
"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital
Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall.
Philips Invivo Corporation issued a Field Safety Notice "URGENT - MEDICAL DEVICE RECALL" letter to all affected customers notifying them that the Expression MRI Patient Monitoring System could pose a risk for patients and users. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the user in order to prevent risks for patients or users and the actions planned by Philips Invivo to correct the problem. This notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. Customers were instructed to contact Philips Invivo Customer Support at (877) 468-4861 (option 1, then option 3) for questions or support concerning this issue.
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.
Kerr Corporation sent "URGENT: MEDICAL DEVICE RECALL" letters to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. US, Canadian, and Rest of World consignees were notified via USPS 1st class mail on June 19, 2012, and Australian consignees on July 5, 2012. Consignees were instructed to complete and return the Acknowledgement Form. Notification of the recall expansion was sent, via USPS 1st class mail, on February 21, 2012 to US, Canadian, Australia and European, consignees; however, once further investigation determined that all unexpired lots of the product were affected, the Alginot recall was expanded a second recall letter was sent to clarify that all lots of AlgiNot FS Volume recall and AlgiNot recall expansion are affected by this expanded recall. Letters were mailed to US, Canadian and Rest of World (ROW) customers on June 19, 2012; Australian and European consignees were notified of the expansion on July 5, 2012. All consignees were instructed to complete the Return Form to acknowledge the updated instructions for use and the added cautionary statement. Consignees not responding are to be contacted at least three times via telephone/fax/e-mail as follow up on the recall.
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
Sekisui Diagnostics Llc sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop using the affected product and to destroy any remaining inventory. A Confirmation of Notification Form was attached for customers to complete and return via fax to 902-628-6504. Contact the firm at 902-628-0984 for questions regarding this notice.
Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton.
Boston Scientific sent a Urgent Medical Device Recall letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed to cease use, quarantine and return unused product with directions to forward the notification to the hospital level. Customers were directed to fill out the Reply Verification Tracking Form and fax to 5086835578, for reimbursement. Returned goods are to be sent to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. For further questions please call (508) 683-4678.
Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2
C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
Allen Medical Systems sent a Urgent Medical Device Recall Notification dated November 18, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Allen Medical will provide packaging materials and instructions for returning your device for repair at not cost to you. Each unit will be repaired and tested. Devices which pass all testing will be returned to the field. For further questions please call 888-521-4277 ext. 4280
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparosco
Some of the sterile packages had broken seals.
Progressive Medical Inc contacted their customers via telephone on December 9, 2011, through December 15, 2011. Customers were informed the reason for recall was explained and the customer was asked if any of the lot remained in their inventory. If inventory remained, the recalling firm sent them a return goods authorization number and informed them the product would be replaced. For further questions please call (314) 961-5786.
Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
Consignees of Medfusion 4000 pumps with software version 1.0 & 1.1 were visited by a Smiths Medical representative on 2/14/12 informing them that their pumps require a software upgrade. A record of this software upgrade was documented as part of the records for this action.
Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. in
Stryker Spine has received reports of the Disc Space Distractors failing during surgical procedures.
Stryker Spine sent an URGENT PRODUCT RECALL letter dated December 7, 2010, via Fedex to all affected customers.. The letter identified the product, the problem, and the action they should take. Customers were instructed to examine their inventory and hospital locations to identify the product. Reconcile IBD Disc Space Distractors with the catalog and lot numbers referenced. Complete the Customer Response Form and distribution sheet and fax a copy of the Customer Response Form to Regulatory Compliance at 201-760-8370. Return the affected product using the enclosed pre-paid mailing label to Regulatory Compliance, Stryker Spine 6 Pearl Court Allendale, New Jersey 07401 For questions regarding this recall call 201-760-8206.
PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
The firm, Dako, sent a "DAKO PT LINK ADVISORY NOTICE" dated May 1, 2008 to customers who purchased the PT Waterbath along with a customer acknowledgement document informing the users of the potential electrical hazard. The notice described the product, problem and actions to be taken. The customers were instructed to follow the attached Safety Instructions; place the enclosed warning labels directly on the instrument as shown in the attached instructions and adhere to the warning labels as described. Customers with questions were instructed to call Dako Products' Technical Support at (800) 424-0021.
Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA Stryker Mantis Rod Inserter Inner Shaft Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA IS2097MAN Mantis Rod Inserter Shaft Used to facilitate insertion and delivery of a Mantis rod.
There have been reports of difficulty in rod rotation using the newly designed Mantis Rod Inserter.
Stryker notified branches/agencies, surgeons and hospitals beginning June 24, 2011 with an Urgent Product Recall letter, dated June 24, 2011, via Fed Ex. The letter identified the affected product, the issue, potential hazards, risk mitigations, and the return process. Customers were asked to examine their inventory and reconcile any inserters and shafts with the catalog numbers provided using the Customer Response Form. Customers are to fax the form to Regulatory Compliance at 201-760-8370 within 5 days of receipt of the letter. The affected product should be retrieved and returned. Questions should be directed to 201-760-8298.
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Medacta USA, sent a Urgent Safety Notification letter dated October 13, 2008, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter informed the customers of the lot numbers on recall and the reference numbers. The recall was initiated because the offset broach handles contain a lever mechanism that is connected to the locking axis by means of a metallic wire. The rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. For further questions please call (858) 705-0350.
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
DeRoyal initiated the recall on 6/16/2012 by notifying customers by overnight delivery of letters describing the problem, instructing the customer how to handle inventory on hand, and requesting the customer to destroy the product, fill out the provided notice of destruction form, and return the form to DeRoyal. For questions customers were instructed to call 865-362-1020 or 865-362-1034. For questions regarding this recall call 865-362-2334.
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System a
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
Alphatec Spine distributors who received the TI Standard Polyaxial Screw Assembly were contacted by phone and by email on December 9, 2010. A phone script was used as a recall notification to contact their three distributors who received the recalled products. The recall notification informed the customers of the problem identified and the action to be taken. Customers were informed that they will receive replacements within 2-3 days. Customers with questions were instructed to call (800) 922-1356. For questions regarding this recall call 760-431-9286.
Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
Touch screen may be unresponsive, inhibiting user input.
All affected US customers and distributors were notified of the Sorin S5 HLM Touch Screen Field Correction by certified mail on 02/15/12. The letter informed users of the potential for unresponsive S5 HLM touch screens and notified them that they would be contacted by the Sorin Service Group to arrange an appointment to replace affected touch screens on site. Customers and distributors were also provided with a Response Form to confirm they had received, read and understood the Field Correction Notice. They were instructed to fax the completed form to (303) 467-6502. For questions regarding this recall call 303-467-6306.
Omnifit M/S PSL Porous Coated Acetabular Shell 40MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.
Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated August 2, 2010, via Federal Express to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory to identify the affected product; retrieve all affected product and return it their branch or agency warehouse for reconciliation; reconcile all product(s) on the attached Product Recall Acknowledgement Form and fax to (201) 831-6069, and return the affected product via Inter-Org Transfer and ship to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product. Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588. Product Usage: The HM II LVAS is intended to provide
A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified
Thoractec Corporation sent an Urgent Medical Device Correction letter on February 23, 2012 via overnight courier and e-mail to all affected consignees. The Urgent Medical Device Correction notification letters identify the affected products, description of the problem with illustrations, symptoms of problem and immediate actions to taken. All users are asked to review the attached labeling, including new caution statements and share with all surgical personnel. Consignees are instructed to completed and returned the Acknowledgement Form indicating that the information was received and understood. Additionally, an update concerning the Worldwide Medical Device Correction Notification is enclosed with each letter. Questions should be directed to Thoratec Regulatory Affairs at 925-847-8571.
IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
Sterility may be compromised.
The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.
Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility.
Teleflex sent a Urgent Medical Device Recall Notification dated September 25, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory and quarantine any affected inventory found. They were to complete the enclosed Field Corrective Action Acknowledgement Form and return it to the Teleflex Medical sales representative who will then remove the affected product from the facility and ensure its return to Teleflex Medical. We sincerely apologize for any inconvenience this action may cause your operations. If you have any questions please contact your local sales representative or Customer Service at 1-866-246-6990.
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as
The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
Abbott Laboratories sent a "PRODUCT RECALL" letter dated October 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to only run ARCHITECT Cyclosporine using Reaction Vessel (RV) lots manufactured with the same resin as follows: a) RV lots beginning with lot 06083P100 and higher can be used together or, b) RVs lots lower than 06083P100 can be used together. Any RV lot number that does not begin with a zero (e.g. 90032P100) should also be considered lower than 06083P100. Further instructions were included for the accounts to follow when running ARCHITECT Cyclosporine assays. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice. A second letter was sent to the accounts on 11/23/11 to simplify the instructions for identifying the Architect Reaction Vessel lots that can be used together for use with the Architect Cyclosporine assay.
Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Ethicon, Inc.
Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
Ethicon sent their recall letters with business reply cards attached on February 2, 2011 via UPS overnight mail. Customers are informed of the issue and asked to return the attached business reply card.
VariSeed 7.1, software application, part number H62, manufactured by Varian Medical Systems. VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.
Brachytherapy device requires the user to enter radioactive source activity, but software may specify unintended units for activity and lead to overdose in patient treatment.
Varian Medical Systems notified direct account healthcare practitioners/ medical physicists with "Urgent Medical Device Correction/Urgent Field Safety Notice" letters by mail on 01/19/2012. Varian's advisory described how to mitigate user error and the firm's intentions to revise Instructions for Use. Technical Support phone numbers were provided for US and international customers.
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was identified in January 2007 a set up process of the automark label printer. All units were corrected in the field in Marc
Terumo field correction/service records were completed in 2007 and all affected units were corrected in the field in March 2007 by replacing the incorrect label at the customer location. For questions about this report call 734-741-6056.
ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Manufactured by Siemens AG, Kemnath, Germany. The indication is to deliver X-ray, photon and electron radiation for the therapeutic treatment of cancer.
Software upgrade to installed base to the latest release of the RT Therapist version 4.1.144 which corrects multiple safety issues that could lead to patient mistreatment.
Siemens customers with active devices will receive the software update through the distribution of the "Update Instructions" with a release date of January 22, 2012. The software update will be delivered and installed by a qualified Field Service Engineer utilizing a SW kit and instruction distributed by the Update instruction. Consignee notification of the Update Instructions will be delivered by Customer Service or by certified mail.
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. This mislabeling was discovered on 29-June-2012 during a clinical case.
NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form. Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical. For questions customers should call 888-632-7071.
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.
The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.
Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall.
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 2170-3000A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
The gap between the two parts of the table may permit pinches to occur on either patients skin or other body parts; it has the potential for serious injury if a patients finger is caught between the pallet and patient table resulting in broken finger bone.
Philips Healthcare issued a Customer Information letter (Field Change Order (#88200402)) dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instruction for use for their system, which states "Monitor the patient and the system vigilantly during any system motions to make sure that ...accessories, equipment, and all ojbects such as hair, jewelry, or neckties-remain clear of any moving camera and imaging table parts. For additional information, customers were istructed to see the BrightView SPECT instructions for Use, section 2.2 - Safety Warnings and Precautions and Safety and Information Labels. Philips Healthcare will notify all affected customers and will install a sticker through an Action for Performance - Proactive Field Change Order (FCO) to resolve the issue. For customers in North America who require further information or support contact Customer Care Solutions Center at 1-800-722-9377, Select Option 5. In all other countries the local Philips Healthcare office should be contacted.
CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.
Terumo discovered through its own testing that the presence of electromagnetic interference (EMI) in the operating room may affect the accuracy of the values displayed by the CDI"101 Hematocrit/Oxygen Saturation Monitoring System: hematocrit (HCT), hemoglobin (Hgb) and Oxygen Saturation.
Terumo Cardiovascular Systems, Corp issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 28, 2011, to all affected customers. The letter identifed the product, the problem and the action needed to be taken by the customer. After a solution has been verified, Terumo CVS will implement a correction for all affected units. Customers were instructed to review this Medical Device Correction notice, Assure that all users are aware of this notice. Confirm receipt of this and to fax back the Customer Response form. For further question please contact Terumo CVS Customer Service at 1-800-521-2818, Monday - Friday, 8 AM - 6 PM EST.
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical ref
There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data
The firm, Vital Images, Inc,., sent a "Urgent Software Alert" letter dated August 23, 2010 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to not use the PET/CT fusion functionality until the software updates are provided and to re-examine any past results. If you have any questions or comments, contact Customer Support at support@vitalimages.com or at 1-800-208-3005.
Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide.
This recall was initiated following a report that a bag labeled as REF. 32-487557/Lot no 2561334 (Vanguard Tibial Resection head universal w/ alignment tower) actually contained a Ref. 32-487002/Lot no. 2561329 (Vanguard Distal cutting Block w/out handle attachment). Investigation found packaging of the affected product may contain the incorrect item.
Biomet U.K. sent a Field Safety Corrective Action notice dated February 14, 2012 to all affected customers. The notice identified the affected products, problem and actions to be taken. Customers were instructed to locate, discontinue use and quarantine the recalled products pending return to Biomet. The letter recommended customers provide the notice to any other organization who may have received the affected instruments. Customers were instructed to complete and return without delay the attached "Fax-Back Response Form" acknowledging receipt of notice and indicating the quantity of products to be returned. For questions call +44 (0) 1656 761658, fax: +44 (0) 1656 645454 and e-mail uk.complaints@biomet.com
Sunquest Laboratory, version 7.0 not available
Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.
Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers with questions were instructed to call (877) 239-6337 for US and Canadian sites and at +44 (0) 161 335 0562 for international sites. For questions regarding this recall call 520-570-2252.
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise
Boston Scientific CRM issued an "Urgent Medical Device Correction" letter dated December 01, 2009. The letter described the issue and potential device behavior. The letter provided recommendations to avoid issues relating to the affected device until improved devices become available. For further information, contact your local Boston Scientific CRM representative, United States Technical Services at 1-800-227-3422, or European Technical Services at +32-2-416-7222.
Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation.
Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.
Philips Healthcare, began notifying customers via telephone on October 11, 2011. The telephone notification discussed the product, problem and actions to be taken. The customers were instructed to not remove a ventilator from a patient without providing a replacement unit; provide a fax number or email address Philips can use to send the Business Reply Form to complete and return via fax to: 800-733-9962 or email: report.request@philips.com; locate their affected devices (if the device is with a patient, replace it with a non-affected unit-Philips will provide a loaner overnight if needed)-(if the device is in their inventory, quarantine it and return it using the RA number provided in the email/fax that Philips sends them); and If loaner units are needed, they are to call 1-877-387-3311 to arrange return of your affected device and to obtain a loaner unit. If you have any questions or concerns, contact Philips Respironics at 877-387-3311.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Sunquest sent an "URGENT-PRODUCT SAFETY NOTICE: PSN-09-06" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.
CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to allow fluid delivery from an IV bag. EXPANDED: Catalog No./ REF 21-7381-01
Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. EXPANDED: Smiths Medical became aware that an additional Product Reorder No. 21-738-01 and Lot No. 21X221 are also being recalled for receiving reports regarding occlusion/high pressure alarms with the use of these set
Consignees were sent a Smiths Medical "Urgent Field Safety Notice" letter dated January 04, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Distributors and other users of these devices. The letter described the details on affected devices, Advise on Action to be Taken by the User and distributor and Transmission of this Urgent Field Safety Notice. Requested consignees to inspect their inventory and remove affected product and to complete and return the attached Confirmation Form. EXPANDED: The additional devices were distributed 12/14/2011 thru 1/27/2012. An Urgent Medical Device letter, dated 3/16/2012, was sent to customers beginning 3/16/2012. The letter identified the additional affected product, described what the issue is and asked that customers return all unused sets to Smiths Medical for credit or replacement. Also, the customer was asked to complete and return an Urgent Medical Device Recall Confirmation Form. If the customer is a distributor, they were asked to pass along the information to their customers.
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.
Sechrist Industries contacted consignees by phone to notify them of a software upgarde and to schedule appointments to perform the required field upgrades. An approximate summary of the phone notification is provided below. "I am contacting you to notify you of a field upgrade we are performing on our hyperbaric chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of your chamber. The upgrade includes the installation of a new motherboard with revised software, a reset switch, and the exchange of other control panel components. The process will take approximately 2.5 hours and will be performed at no charge to you." For questions regarding this recall call 714-579-8400.
LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.
Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software may not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.
Consignees were sent on 8/12/11 a Boston Scientific letter dated August 2011. The letter was addressed to "Dear Doctor". The letter described the product and problem. It also gave Background Information, Description of Potential Data Translation Error, and Additional Information and Action information. A letter, including an HRS form, was also sent to all US LATITUDE Clinics that have active LPI software to notify them of the need to install the corrected LPI Software.
Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 Boston Scientific, LATITUDE RF Communicator & Software, Model 6482.Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 LATITUDE Communicator REF 6468 (only distributed outside the US) The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scien
A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.
Boston Scientific CRM Corporation sent a " Dear Patient", letter dated August 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new communicator is being shipped separately to you with a corrected security certificate that will allow it to be activated and function normally. 1. Please activate this new equipment at your convenience to begin home monitoring. Activation instructions are enclosed with the communicator. 2. We also ask that you return the original communicator previously delivered to you: " Place the original equipment in the shipping box used for the new equipment. " Pack newspaper or other filler around the equipment to prevent damage during shipping, and seal the box. " Enter your address in the FROM section of the prepaid Federal Express label, and apply the return label to the outside of the box directly over the original label. " Call Federal Express at 1.800.463.3339 to schedule a pick-up. We apologize for this inconvenience. If you have further questions, please call 1.866.484.3268.
ACCU-CHEK Aviva Nano Blood Glucose Meter No product labeling, beyond the labels applied to the meter, was provided with the meter as these meters were never intended to be distributed. A representative copy of product labeling that would have been included in a finished device kit is attached. The Accu-Chek Aviva Nano Blood Glucose meter is intended to be used with Accu-Chek Aviva test strips for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn fro
Accu-Chek Aviva Nano Blood Glucose meters that were manufactured for the purpose of validating a manufacturing process for product to be distributed outside the US were distributed in the US through eBay by an unauthorized third party. These meters were not intended for distribution, were not verified to meet final product specifications and were not distributed to customers with the necessary pr
Roche sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to immediately return their ACCU-CHEK Aviva Nano Meter to the firm in an enclosed pre-paid envelope via USPS. Contact Roche Product Removal Services at 1-888-345-5352 between 8:00 am and 5:00 pm for questions regarding this notice.
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
SenDx Medical sent a recall letter to all their foreign customers on January 6, 2010, to informed them of the ABL80 FLEX CO-OX recall via the Radiometer Field Action Notification (FAN) system. The Field Action Notes informed the customers of the problem identified and the action to be taken. Customers were instructed to submit confirmation fax#1 to confirm that the customer letter has been distributed to all ABL80 CO-OX customers by January 31, 2010. Customers were instructed to submit confirmation fax #2 to confirm that all ABL80 CO-OX analyzers have been upgraded to version 1.35 by 6/30/10. In the U.S., the customer was provided with a software upgrade CD along with a letter advising them to the issues associated with the recall. Customers with questions were instructed to contact TechLine at (800) 736-0600 opt 2.
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F.
"Urgent - Medical Device Correction" letters dated 12/12/2011 were sent via USPS 1st class mail to all customers and again on 2/21/2012 for recall expansion. The device issue was described and recommended actions were provided. Customers were instructed to acknowledge and complete the Return Form. Questions were referred to (800) 854-1741.
Clinac High Energy Medical Linear Accelerator, a Trilogy Radiotherapy Delivery System; Model #s: H14, H18, H27, H29, HCX; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereot
The wedge angle labeling on the wedge tray may not correctly match the wedge body. However, the wedge body is labeled with the correct wedge angle.
The firm, Varian Medical, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 24, 2011, to all affected users. The letter described the product, problem and actions to be taken. The customers were instructed to IMMEDIATELY inspect all wedges to verify that the wedge angle label on the wedge body matches the wedge angle on the wedge tray; if any wedge is identified with mismatched labeling follow the written instructions provided in the letter; always measure wedge data at installation of new or replacement wedges; verify all treatment accessories of "matched" linear accelerators, and please advise the appropriate personnel working in your Radiotherapy Department of the content of this letter. Varian has enhanced their manufacturing quality control process to further ensure correct labeling of wedges. Also, Varian will replace any wedge that is identified as mislabeled, at the request of the customer. If you require further clarification, please feel free to contact your local Varian Customer Support Service Manager at: 1-888-VARIAN5 (888-827-4265) for USA and Canada; +14 41 749 8844 Europe; North American: support-americas@varian.com; Australia/New Zealand:support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.helpdesk@varian.com; Japan: Japan.apps.helpdesk@varian.com; Latin America:soporte.al@varian.com.
LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft fur medizinische, Sondentechnik mbH, Dorfstrasse 2, 24247 Mielkendorf, Germany; Distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, New Jersey 08536 USA. Used for continuous determination of oxygen partial pressure in cerebrospinal fluid and brain tissue.
Certain LICOX CMP Tissue Oxygen Monitors could allow for underestimation of temperature values.
Integra Life Sciences notified their Integra Neurospecialist via email and their customers via Fed Ex overnight mail on December 17, 2010 with an Urgent: Product Recall letter. The letter identified the affected product and the reason for the recall. The letter states that an Integra Neurospecialist will contact customers to arrange for the return of their Licox monitor to the Service Center for recalibration. A loaner will be provided until the recalibration is complete. The attached "Recall Acknowledgement and Return Form" must be completed and returned to Integra. If there are any additional questions, customers should contact Gary Rabinovich at 609-936-6864.
Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 surgical kits
The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex.
DeRoyal Industries sent a Customer letter dated January 6, 2012, to the affected customer. The letter identified the product the problem and the action needed to be taken by the customer. An email was also sent on January 10, 2012, to the affected customer. The customer was requested to follow these instructions. 1) Identify any affected inventory using the product and lot numbers on Attachment 1. 2) Attach the provided warning label to each affected kit and tray. 3) Forward this recall to any of your end users that may have affected product. 4) Complete and return Attachment 1 by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter, even if you no longer have affected inventory. If you have questions or need assistance with the recall, including additional labels, please call (865) 362-1037 . We apologize for any inconvenience this may caused you.
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to
Leakage in Cepheid SmartCycler reaction tubes.
BD Diagnostic Systems issued an Urgent Product Recall letter via UPS overnight delivery on May 22, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue use and discard any affected product. BD would send replacement tubes for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance FAX: 410-316-4258 Email: RegulatoryComplianceFax@bd.com If further assistance is needed, customers should contact BD Technical Services Department at 1-800-838-8663. For questions regarding this recall call 410-316-4054.
HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary and venous whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near pati
ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system.
ITC-Nexus Dx, Inc. sent an Urgent Medical Device Recall letter with return response forms to end users and distributors dated January 21, 2011 via UPS overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they had an of the affected lots. If they have full boxes or loose containers of the affected lots customers were instructed to stop using the product and remove it from inventory. Customers were requested to fill out the return response form and send it back to ITC via fax, email or mail. For questions customers were instructed to call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (International)), Extension 4707 or e-mail techsupport@itcmed.com.