FDA Device Recalls in 2007
460 recalls found
December 2007
CryoValve, Pulmonary Valve & Conduit
Donor tissue was released prior to information received regarding a pericardial effusion.
Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife
CryoValve, Pulmonary Valve & Conduit
A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
The physician was notified by letter on 07/15/2004.
Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles
Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.
EMD Chemicals via fax and mailed an Important Product Recall letter dated 7/30/07. The letter notified end use consignee that after conducting an investigation it has determined that Harleco May and Grunwald's Stain; 0.17% w/v Item #660/75 % 660/85 has unacceptable levels of azure and eosin absorbance and undissolved dye matter. Users were requested to discontinue shipping and return product. Wholesalers were advised this is a Customer Level Product Recall and requested to sub recall product sold after 7/5/07.
Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.
Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.
The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com.
Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.
Some product containers may be leaking.
The firm contacted consignees via certified mail and e-mail, initated on March 29, 2007.
Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538
Mislabeling: Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.
Boston Scientific issued a letter to all consignees by mail on June 14, 2007, titled Urgent Medical Device Recall or Correction - Immediate Action Required. The letter describes that the expiration date is incorrect. Discontinue use of the product, segregate it, complete the Reply Verification Tracking Form and fax it to Boston Scientific. Call 888-272-1001 to obtain a Returned Goods Authorization (RGA) number.
Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7'' to a high position of 30''. The beds are distributed by SIZEWise Rentals, Ellis, KS.
The bed may drop due to a malfunction of the actuator exceeding its stop.
The recalling firm met with their one customer on/about 11/14/05 explaining the reason for correction. The customer then notified their company stores and dealers via service bulletin dated 2/28/06 that they would be receiving new acutators for replacement on the beds. The actuators were sent to their company stores and dealers in early March.
Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.
Components may not lock together as intended.
Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.
Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Ann
Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.
Boston Scientific sent an Urgent Medical Device Recall -- Immediate Action Required letter to consignees on 10/12/07. The letter described the product and the mislabeling problem (labeled outer carton and pouch as 4F when they are actually 5F devices). The firm recommended segregating the affected product and to return it to Boston Scientific PLEASE NOTE: The firm's recall letter incorrectly addressed the mislabeling of this product recall. The mislabeling involves the labeled outer carton and pouch were labeled as 5F when the device enclosed in the pouch was a 4F device.
Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delive
Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.
Ogenix began notifying their customers of the recall via telephone on 3/24/2006. All thirteen (13) customers were initially contacted via telephone. Those customers which could not be reached were contacted by mail. Three (3) attempts were made via telephone with the fourth attempt being made by letter until all of the customers were reached. The customers were instructed to destroy all CUGs in their possession and the distributor/customers were asked to contact any of their customer(s) who may have received the incorrect CUGs and request that they destroy the brochures.
Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX
Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.
Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.
Jostra HL-20 Heart Lung Machine - guiding pins
The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.
An 'Important Safety Notice - Please Read Immediately' letter was sent to all US customers on 10/3/06 by FedEx Return Receipt.
Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.
The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.
Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.
Method is susceptible to positive interference from endogenous ALT in patient samples.
The firm has updated the Limitations section of the Ammonia Reagent Package Insert and circulated a Technical Bulletin dated July 24, 2007 to all customers that have purchased Ammonia Reagent that is still within expiration date. A Notification of Change has been introduced and shall be placed within subsequent Ammonia Reagent Kits with a copy of the updated package insert; the notification of change informs customers that a change has been made to the package insert. Notifications of Change are placed within kits for 6 months from the date of issue.
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.
VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San Jose, CA 95138
Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.
The recalling firm has issued customer notification letters by mail on 03/06/2007. The firm is requesting that consignees discontinue their use of the device and return recalled product . The firm will provide replacements.
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.
Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
Ultrasound probe cover, sterile. Catalog No. 910811.
Customer observed unsealed packages.
The recalling firm called their customer and requested the customer to return un-sealed packages.
Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide.
Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures.
The firm sent out recall notification on 5/4/2006. The US consignees were sent a letter via return receipt.
Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio
Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
The recalling firm sent recall letters dated 1/23/2007 to their Distributor Customers and Non-distributor customers who received Salivart product from Lot Code: 06AA003. both letters include an attached recall response form which the customers are instructed to destroy the product, complete a form and fax back it to the recalling firm. The response forms provide verification that the form has been received by the customer(s). With the initiation of the RECALL EXPANSION for more lot codes to be recalled on 2/14/2007, the firm issued new recall letters dated, 2/13/2007, 2/15/2007 and 2/22/2007. These four letters provide the same basic information and also have attached recall response cards, however, they list the additional 6 lot codes subject to recall. The firm issued a Press Release concerning this recall through Cleveland (Business Wire) on 3/1/2007.
VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.
Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.
Ortho-Clinical Diagnostics sent "Urgent Product Correction/Recall Notification" letters, dated 3/28/06, to the customers via overnight mail. Ortho-Clinical Diagnostics issued a nationwide press release on 3/31/06. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results are recommended to discuss this matter with their physicians. Ortho-Clinical Diagnostics has advised laboratories, using this reagent, to contact the patient's physician if there are any concerns regarding previous test results. Customers with questions may contact the company at 1-800-421-3311. Additionally, Ortho-Clinical Diagnostics notified all end users of the VITROS ECi/ECiQ Immunodiagnostic System in the US and globally.
Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
Lights split, spilling contents when bent to activate.
Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.
Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125 1130023-A: GN Targeting Guide Carbon 135 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve New Guide Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsteril
PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.
Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
The device was produced without the required distal locking hole
The initial depth of the withdrawal action taken in June, 2003 ,was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.
Notification will take place to the wholesale (agent) level via telephone calls from PLUS USA''s Customer Service Department on/or about June 20, 2006. Each location will be contacted to determine if they have any affected devices. If so, they will be issued an RMA with the request to return any affected devices as soon as possible. Returned devices will be sent to the manufacturer for repair.
VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 1214332 VKS Tibial Prep Guide, Right/Left, Size 2 Lot Code EM.l and EM.6, 1214333 VKS Tibial Prep Guide, Right/Left, Size 3 Lot Code EM.1; 1214334 VKS Tibial Prep Guide, Right/Left, Size 4 Lot Code EM.5; 1214335 YKS Tibial Prep Guide, Right/Left, Size 5 Lot Code EM), Plus Orthopedics
The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.
The initial depth of the withdrawal action taken November 2006 was to the distributor (agent) level. On 11/27/2006 Plus Orthopedics USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA. Agents were notified by telephone to check their inventory and return any affected units. A telephone script was used.
OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076
Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.
An Urgent Medical Device Recall Letter dated 16 July 2007, was issued via E mail and Fax on/or about 7/18/2007 directing consignees to remove unused cassettes from inventory and destroy them. Replacement cassettes will be shipped upon receipt of information regarding destruction by calling customer service at 800-490-6784. Sub-recall by distributors was requested.
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004 Femoral Component Size 4, 26006 Femoral Component Size 6, 26008 Femoral Component Size 8 and 26010 Femoral Component Size 10
There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.
The depth of the withdrawal action taken in June, 2003 was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.
Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)
The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction.
On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07.
Plicator EPS Plication System Catalog Number: 160-01128R
Device arm may fail to open after being deployed and require surgical intervention to remove
NDO Surgical notified accounts by letter on 1/26/07 advising to quarantine units. Replacement units are being sent and recalled devices are requested to be returned.
Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100
Guidewire restriction during use (excessive adhesive in the guidewire lumen)
On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.
AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or mask); Cardinal Health, McGaw Park, IL 60085; cat. 006900
Under isolated conditions, the device may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance.
Cardinal Health sent the accounts recall letters dated 6/1/07 via UPS next day delivery, which listed the catalog number and affected serial numbers of the CPAP Driver, and informed them that under certain isolated conditions, the CPAP Driver may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance. Customers have experienced this under the following conditions: 1) air inlet pressure is greater than O2 pressure by 5 to 10 psi and 2) FiO2 settings less than 45%. Separate recall letters were sent to those accounts who had filed complaints of O2 Calibration Errors, stating that their device will be replaced by the end of June, 2007; those accounts who purchased the devices, but had not reported O2 Calibration Errors, stating that a Cardinal Health representative will upgrade the firmware on the devices at their facility by the end of August, 2007; and those accounts who had had demonstration units in their possession, advising them to notify their sales representative if any of the conditions mentioned in the letter occurred. The accounts were requested to complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of affected drivers in their possession, and were advised that they would be contacted by a Cardinal Health representative to arrange for the replacement/service of their drivers. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332 or 1-800-327-7503.
Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402.
Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.
As the complaints were received (between 07/04 and 01/06), the firm visited the customer filing the complaint and repaired the pumps demonstrating the problem. The firm will correct other units as complaints are received. The firm modified its recall strategy and issued a Device Correction Letter dated 6/22/07 notifying all users of the problem
Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110
Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit
Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.
Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case. The label shows the product is Manufactured by Southwest Technologies, Inc., North Kansas City, MO.
The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
Recall letters were sent to all direct accounts via certified mail on 3/27/2006. The consignees were requested to return any affected product on hand and if the product was further distributed, notify their customers.
Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021
The 9F device may contain a 10 F sheath instead of the 9F
United States Surgical notified accounts by letter dated 5/22/06, requesting return of inventory. Distributors were requested to provide customer list to USS for contacting customers.
FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.
Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.
HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.
GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.
Consignees were notified of the problem by a visit. To address the Proteus System shipped to the field, a Field Modification (FMI) was created to correct units in the field.
HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.
Baxter sent Urgent Device Correction letters worldwide to their customers on 6/21/05 and home patients on 6/22/05. The accounts were informed of teh risk of electrical shock from screws used to secure the Power Entry Module to the back of the HomeChoice system, and were instructed to always connect the power cord to the power entry module first, before plugging the power cord into a grounded electrical outlet. The users were advised to use caution to avoid contact the power entry module screws while powering on or powering off the device, and were informed that a new mounting bracket that providews more reliable grounding was installed in instruments processed through the Baxter service organization as of May 2005. All remaining instruments will receive the new mounting bracket by August 2006, and Baxter will contact the accounts to arrange for the upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.
Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China
Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
Field Modification Instruction : FMI 67631 (DEC 2006) was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. Corrections were performed in DEC 2006
Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430
Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod
Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.
Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553
Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
Recall letters were sent on 6/09/05 by FedEx to direct wholesalers/distributors and retailers nationwide. A nationwide press release was issued on 6/10/05, and notification sent to numerous consumer & parenting publications, plus posting on company website. Questions from consumers should be referred to Del Pharmaceuticals at 1-800-818-1915 or by email at consumer_relations@orajel.com. Recall letters were sent to 3 direct accounts on 7/21/05 via FedEx after the discovery that these accounts had not been notified.
HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.
Urgent Device Correction letters dated 5/24/04 were mailed to the peritoneal dialysis nurse of facilities identified as having patients who use the HomeChoice machines. The letters informed them of the potential overfill problem and requested that they review the patient list provided with the letter and verify that it was complete. The nurses were requested to communicate the information to their home patients, and visit all of their patients who use the device in the low I-Drain Alarm Volume mode to make an interim correction, permanently changing the I-Drain Alarm Volume from OFF to 0ML in the Make Adjustments menu. Permanent software corrections will be installed when the revised software becomes available. Follow-up letters dated 1/12/05 were sent to the Home Care Coordinators, providing them with an addendum to the HomeChoice Trainer's guide, repeating the information from the 5/24/04 letter and providing additional information to safely disconnect from the HomeChoice system during therapy. The letters also included copies of the 1/14/05 letter sent directly to the HomeChoice home patients, as well as addenda to the Patient Help Cards and Patient At-Home Guide.
HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines. The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.
Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.
HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441R
The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.
Baxter sent Urgent Device Correction letters to the Peritoneal Dialysis Home Care Coordinators on 11/1/04 and to the Home Dialysis Patients on 11/2/04. The consignees were informed of the potential for a shock if the power switch loosens in the housing, and that the switch would be replaced with a grounded power switch on a next service call basis. If the patient experiences any difficulty turing the device on or off, or if they notice that the power switch is loose, they were instructed to immediately unplug the device and contact Baxter Global Technical Service (BGTS) at 1-800-553-6898, option 1, for immediate assistance.
STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France
Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
A recall notification has not been sent. The firm did issue a technical bulletin to their representatives.--Update: based on FDA input the firm issued a Recall Letter to all users dated May 25, 2007