FDA Recalls in 2003
213 recalls found
November 2003
Optima Poly Screw Driver.
Reports of pieces chipping off the tip of screwdriver during use.
Consignee was notified by letter on 8/18/2003
Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro diagnostic use
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
PerkinElmer notified all customers who received the lots by telephone by July 23, 2003 followed by letter dated July 25, 2003, which includes instructions for documenting receipt and lot removal either by destroying or returning product to PerkinElmer
BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
Recalling firm notified distributors and end user by letter 8/11/03 and advised of product failure. Consignees were requested to discontinue distribution and use and discard product for replacment. Consignees were requested to return response form.
Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2, CIBA Vision Corp., Duluth, GA 30097. USA. The product is packaged and distributed as 15 and 30 packs.
Lenses may be labeled with the incorrect axis.
Consignees were notified by letter via Airborne express mail on May 6, 2003. They were advised to return any of the affected lots remaining in their inventory to CIBA Vision, with the letter, a business reply form and a pre-paid air bill sticker provided by the recalling firm.
MagNA Pure LC Instrument; Catalog number 2236931.
Potential for false negative patient results with software version 3.0
An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system
Pouch containing pediatric probes was labeled as containing adult probes.
The 3 consignees were notified by telephone on 09/24/2003, followed by a letter.
Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093, Tel: +1770-717-0904, Fax: +1770-717-1283, 1-800-NOVOSTE (1-800-668-6783), www.novoste.com.
Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected.
Customers were notified via Advisory Letter followed up with a Recall Letter and Customer Informational Letter on/about January 24, 2002. Customers were advised to discontinue use of the product and return the affected product to Novoste Corp. to be recalibrated to obtain a correct calibration certificate.
LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000
Outer kit mislabeled with an extended expiration date
Vasca ,Inc. initiated their field action by letter on 9/22/03, advising accounts of the incorrect expiration date and requiring them to follow instructions to relabel the outer kit and the Exchange kit with the correct expiration date label provided. Vasca personnel will visit and verify the correction was completed. A Label Verification form will be completed by the Vasca personnel and returned to Vasca.
GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR
Finished products were not sterilized.
Medegen has notified all direct accounts by certified mail on 4/30/03.
Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
Sterility compromised - incomplete sterile package seal.
The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall.
Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 cc; order number PVA-50.
Bottle contains less product than is declared on the label.
A recall letter dated July 1, 2003 was sent to all customers receiving product during the recall time period asking for a return of the product.
Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
Non-sterilized product sold as sterile.
Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail
Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product.
Trident Insert Impactor
The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
Howmedica sent recall letters and acknowledgement forms via FedEx on April 29, 2003 with return receipt.
CoaguChek PT test strips, sold in 12 pack.
Discrepancy between INR and the % Quick displayed on the meter.
Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.
Barrier Hip Sheet with Side Pockets
pouch may tear which could result in contamination of sterile field
The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.
Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
Instrument is excessively flexible making it unusable by the surgeon.
The firm mailed a Recall Notification Letter to each account on June 17, 2003 asking them to cease distribution, return recalled product to them and to subrecall to any accounts they may have distributed to.
EM2 NC AEM Monitor (NON-COM)
Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Accounts were visited by sales representatives beginning 6/23/2003.
Atakr II RF Power Generator, Models 4802 and 4803
An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.
Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..
Did not meet finished device specifications for the DNA criteria.
Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.
LMA- Unique Laryngeal Mask Airway Size 4, Catalog No. 12140, Lot FH041202 Size 4, Catalog No. 12150, Lot FJ021202
Sterility cannot be assured
Recall letters were issued on June 18, 2003 to customers. It requests return of product and included a request to fax back inventory description.
October 2003
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
The check valve in the patient line may stick in the closed position.
Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
The firm mailed or faxed a recall letter to consignees on May 14, 2003 followed by a phone call to each account within two weeks to arrange for a service technician visit to correct the monitors. The recall letter warned the hospitals of the problem and a work around.
Clinitron At Home Air Fluidized Therapy Unit
Power cord overheating
Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.
propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a
Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading.
On 8/9/02, Propper faxed a 'Request for Return' of the product to the consignees advising them of the problem and that a replacement will be sent for all returned product. On 11/27/02, Propper faxed a second 'Request for Return of Product' to its consignees. The firm destroyed the recovered and held stock.
ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
Microscope Slides contaminated with fungal material
On 1/29/03 the firm issued a letter advising users of the problem and requesting they cease using the slides for preparation of non-gynecological cytology specimens. Replacement product has been shipped.
Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325
Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm
Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.
CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305
Product's sterility is compromised due to a failed sterility audit
Blue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.
Channel Neuroendoscope, Standard Resolution, 21.6 cm. Catalog No. 2232-001
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Firm sales representatives will contact customers and hand deliver the recall notice.
Assorted colored and flavored condoms: LifeStyles Luscious Flavors, Prime Assorted Colors, Contempo Luscious Flavors, Contempo Intensity Assorted Colors
The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
Recall letters dated 11/25/02 were issued to direct accounts via U.S. Mail, asking wholesalers to stop distribution of the lot, return stocks on hand, and conduct a recall to the retail level.
BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
Bi-Ventricular support system may switch to battery when primary voltage (AC) is available
Abiomed notified customers by letter on 8/19/03 advising users of the problem and requesting that the unit not be used until a field service representative corrected the device.
CryoValve, Pulmonary Valve & Conduit SG
The heart valve procurement exceeded the warm ischemic time criteria.
The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003.
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
The firm sent notification letter and modified operating instructions by mail on March 28, 2003.
StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.
Set tubing disconnected from the male luer lock during use on patients. Misassembled.
A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.
ACCESS Estradiol Reagent Test System
Short volume, resulting possibility of falsely elevated results.
Consignees were notified by letter dated may 8, 2003. It requests destruction of inventory for credit.
Gemstar 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version
Products contain software deficiencies which could allow over infusion thereby administering excess medication.
On 4/1/03, the firm issued letters via Federal Express Overnight Delivery to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
TransFx Pin, External Fixation Pin. 3.0 /4.0 mm x 80mm, 20mm thread.
Mislabeled; wrong identification number on pin.
Recall letter was sent on 2/10/2003 to Zimmer Patient Care Division. The letter states that Zimmer is to conduct a sub-recall to their customers to account for the 127 pieces sent to them.
HeartMate Stroke Volume Limiter (SVL) Catalog # 1295
Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.
The firm issued a Safety Bulletin and Safety Instructions to all consignees via certified mail with return receipts on 2/7/03.
Access and Access 2 Immunoassay Systems 862.2160 Discrete photometric chemistry analyzer for clinical use.
Spring failure, design defect in component.
A mandantory field modification was issued on 12/19/2002 to install the new spring on a next call basis unless a new spring was already installed (ie. recent purchase equipment)
September 2003
Y-Type Blood/Solution Set, catalog #1C8029; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 111'' long, 10 drops per mL; Baxter Healthcare Corporation, Deerfield, IL 60015
Leakage may occur at the inlet port
The affected product codes and lot numbers were recalled by letter dated 12/18/02. The customers were informed of the potential leakage at the inlet port, and were requested to inspect their inventory for the affected products and destroy those found. The accounts were requested to complete the enclosed reply form and certificate of destruction and return them to Baxter for credit issuance.
T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
The device does not have an oblong hole for dynamic locking as required.
Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.
ICON DS hCG, an in-vitro diagnostic. Part number 44025.
Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product.
Hill-Rom brand Affinity three birthing bed
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
On 5/19/03, the firm issued letters via overnight express to all its consignees, informing them of the affected devices and providing instructions on the recall.
Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s: FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF; FB720VL, FB730VL, FB820VL, FB830VL; FB720F, FB730F, FB740F, FB760F, FB820F, FB830F, FB840F, FB860F; FB720L, FB730L, FB820L, FB830L
During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.
A letter was sent to each US commercial accounts via UPS overnight mailing on Saturday, March 1st, 2003 for delivery on Monday, March 3rd 2003. The notification instructs firm''s customers to sequester product from the specific lot numbers so that firm''s rep could assist in removing the affected product.
Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb)
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
On 3/24/03, the firm issued letters via US Mail to all its direct consignees informing them of the affected device and providing instructions on the recall.
Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
A recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests return of the devices.
DrugCheck 3 Test Cup COC/MET/THC Product Code 60300
Label lacks professional use legend and name and address of the manufacturer.
The firm sent a letter to customers requesting that they overlabel their stock on 3/20/2003. This recall is complete.
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow
Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
Baxter issued a Safety Alert letter dated 11/15/02 to the direct accounts informing them of the potential for incomplete disinfection of the Meridian instrument during the Renalin/Formalin disinfection cycle due to electomagnetic interference (EMI). The accounts were informed that they will be receiving a radio frequency interference (RFI) filter kit and installation instructions to eliminate EMI by 2/28/03. The accounts were given instructions to follow to ensure that the Renalin/Formalin disinfection cycle has been completed prior to use of the machine.