FDA Recalls in 2006
456 recalls found
March 2006
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
Reports of false negative results on Sysmex Coagulation System.
On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.
STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.
February 2006
Roche Elecsys total PSA, catalog number 11731262322.
There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.
A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm).
On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason.
Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
The Calibrator included within the kit may be losing reactivity.
All customers were notified via recall letter on June 12, 2003. Letter sent out via Airborne Express. All product is to be returned to Zeus or destroyed.
Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
V.A.C. ATS Canister with Gel (500 mL), Part #M6275063/10.S, distributed by Kinetic Concepts, Inc., San Antonio, TX. Product is labeled as STERILE.
Possible mislabeling of shipping cartons.
All hospitals and nursing homes contacted via letter and by phone.
Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.
The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.
On 7/20/05 Spacelabs called the consignees that received the units to notify them of the hazard and also the schedule a service call to repair the affected capnography modules. The firm will confirm that all consignees have been updated with the appropriate PCBA and will audit the device recall records for completion.
Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.
Genesis Uni Articular Inserts
The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.
Viridia/Agilent Information Center Model : M3150A#C01
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
Philips Medical Systems notified users by Certified Mail on/about 2/19/03 that the firm was initiating a device field correction (recall) to conduct an upgrade to units witha HP VL400 or VL420 computer which is cconfigured for dual display by replacing the video and network communication card. Previous to this notification, Philips sent letters on 1/2/03 addressed to Biomedical Engineering Manager to advise users to reboot the system in the event of a system freeze.
Tru-Link DIN unshielded ECG cable, 5-lead
ECG 5-lead cable miswired - A physician could interpret the incorrect polarities as a conduction defect.
On 9/16/05 the firm sent a letter to their customers advising of the problem. The customer was requested to check the code on their cables, and if the suspect code, discard the cable. The customer was provided a response sheet to indicate they received the notification and to request new cables.
Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.
Easy Access Image Management System with CL.Net.
Failure to update correctly when re-transmitting an image from the modality.
The firm mailed a letter on January 31, 2005, certified return receipt to their customers advising that a service representative will visit each site and install new software.
Misys Laboratory version 6.1 - Microbiology Module
Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000.
Telephone calls and emails dated 9/29/05 to all consignees in production. Product Safety Noticed dated 9/29/2005 was faxed to all consignees testing the product.
Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811
X-Ray system may fall downward and could possibly hit the patient.
A notification was sent to all customers via certified mail, return receipt requested starting on December 1, 2004. Field Service Engineers will contact the customers to schedule a time for the column exchange starting mid-November and to be completed no later than Mid June 2005.
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
Potential for positively biased results in QC and patient samples.
Letters dated 3/15/2005 sent First Class Mail. Customers are advised product will be replaced. The letter includes modified quality control procedures that will pre-qualify each reagent pack.
Misys Laboratory with Lab Access Results application for versions 5.3 and later.
Software anomaly may rarely allow modification of previously reported specimen results.
Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.
Xcelera R1.2 Cardiology image and information management solution software.
Loss of image data from image repository and archive requiring patients to undergo repeat imaging.
The firm notified hospitals via letter sent 12/21/2004 stating the service organization will perform onsite upgrades.
EasyDiagnost Eleva Part Number 989605071921
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
The firm mailed letters via certified mail to their affected customers beginning on June 8, 2004. The letters instruct their customers to modify the default display on the ViewForum to exam/series date and time until a service representative can install the upgraded software R3.2.
BV25 Mobile X-Ray System
Potential for c-arm to move due to loose screws
Beginning on 7/20/04 the firm sent a letter dated 7/19/04 via certified mail. Mailing was completed 7/27/04. The letter advises customers of the problem, advises how to determine of the screws are loose, and if so to contact Philips. The letter also advises that a respresentative will visit each consignee to inspect and correct the problem.
NT Intera Magnetic Resonance Image System
Potential for patient burn
On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
Potential for device to cause burning of the skin.
On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.
XPRT Therapy Mattress Systems: Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen c
Design control/validation deficiencies.
Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.
Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; 6230-3-024 T3 MOD REV DIST STM 24MMX225MM
Restoration T3 Revision Hip System distal stem has demonstrated fractures.
Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.
ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL
Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
Written notification was sent via letter with corrective software beginning on March 4 to the end users.
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
The firm began notifying family members of pediatric patients via phone on 7/15/05 and immediately began shipping a recall letter and 10 packs of replacement adapters to each pediatric user. Attending physicians were for these pediatric patients were notified the week of 7/18/05 via phone and follow-up letters were sent to these physicians. The firm is issuing a press release on 7/28/05. Only these replacement adapters are being sold by Disetronic to users of any age ordering new adapters.
PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.
Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.
Pentra 80 and Pentra 80XL Hematology Analyzers
Software defect, instrument may erroneously give a result of '0' or '---'.
Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA
Lumens may have incorrect lumen size marked on them.
Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Adverse trend in stability, controls biased or out of range.
Recall was initiated by phone using a script, to be followed up with a letter and response form.
BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25
Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.
The recalling firm notified distributors by letter on 11/23/05 and advised that identified lots of the devices contain a component contaminated with the bacteria Ralstonia picketti. Distributors were instructed to discontinue distribution and discard. Distributors were requested to provide consignee lists to the recalling firm for direct notification to consignees. Distributors were notified that the recalled products have been discontinued. Customers are asked to discard Liquid Activating Reagent Packets and return the response form enclosed for replacement of the packets or alternatively use existing packets by adding user supplied de-ionized or sterile water into the reagent channel of the pouch.
January 2006
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
The device has the potential for overheating its transformer and has the potential for fire hazard.
The firm sent notification letters to its consignees on 2/18/05 and 5/18/05 via FedEx. On the letter, a service reply form is included to monitor responses and schedule appointments to replace the PAM unit component.
CryoValve, Pulmonary Valve & Conduit
Records noted that the infant donor's mother had tested positive for Hepatitis B.
Physicians were notified by letter on 12/17/2004.
Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.
Varying degrees of difficulty were encountered when opening and closing the InnoValve.
Consignees were notified via Federal Express letter on/about 09/28/2005.
SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units
Sheaths may fracture if exposed to excess fluorescent light
The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.
Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
There is a potential for the lumen to collapse and prevent passage over a guidewire.
Consignees were notified via overnight courier on 11/7&8/2005
Animas IR 1250 Insulin Pump.
pump failed to respond to keypad button pressess after using the food database feature
The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.
Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT
stress crack on the stopcock
The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
Evita 4 Continuous Ventilator
software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
The recalling firm issued recall letters to the accounts dated 5/7/03.
HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT.
Water permeability of the patch is out of specification.
Recall letters were sent to the customers via US Mail return receipt on 12/30/2003.
ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
concentrations for normal samples generated with current reagent lots of the ARCHITECT Folate assay are lower than data generated for the package insert.
Abbott international affilates were notified of the recall by e-mail on 03/11/2005, and requested to notifiy their customers. The letters inform the end users of the downward shift in control and/or patient results, and requested them to assess their normal and deficient ranges for their specific population, assess their quality control ranges and follow their laboratory procedures for reviewing patient results and notifying Health Care Providers that they serve. There was no U.S. distribution.
XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA
The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay.
On 6/27/05, Abbott sent the customer letter via FedEx to all XSYSTEMS Multiconstituent Controls customers that received List Number 9687-12 lots 17270M100 and/or 18177M300 and/or AxSYM Opiates reagents (List Number 3B25-20) since June 01, 2004. The letters explained that the multiconstituent control ranges for morphine were not updated in the MCC Accesory insert at the same time they were updated in the AxSYM Opiates reagent package insert in 2004. The accounts were requested to review their current control ranges for the AxSYM Opiates assay, and verify that they are using either the control ranges in the AxSYM Opiates reagent package insert or control ranges established by their facility. They were also instructed to follow their facility''s normal policies and procedures for communicating with health care providers served by their laboratory. The accounts were requested to complete and return the enclosed reply sheet acknowledging the receipt of the letter and the dissemination of the letter to the laboratory manager/supervisor responsible for the assays.
Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product.
Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.
Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585.
The bit may bend or fracture during use.
Consignees were notified to return the product via letter dated 11/10/05.
Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025 and 100512020
Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
6 cm Catheter Reservoir with 10 cm extension
stylet in package is shorter than that claimed on the label
The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.