FDA Recalls in 2003

Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic ba

On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.

Consignees were notified by letter on 8/29/2002. They were advised to pretest the catheter prior to inserting the catheter into the urethra.If the pretest indicates that the catheter balloons do not inflate as labeled, they were advised not to use the product and to contact Bard Medical Division Field Assurance Manager to have the product returned and credited.

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)

Product may elicit fluorescent signal interference due to bacterial contamination.

On 1/31/03, the firm initiated the recall and their notification was via letters requesting 'locate and discard' affected device.

VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x

The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.

On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release.

IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064

The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.

Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.

Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made from the same raw material. The accounts were informed that the Architect Calibrator was performing as expected, but as a precaution recommended conducting a daily QC with non-Abbott Controls and to report back to Abbott any out of range non-Abbott control results.

Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.

Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.

Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)

Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.

On 5/13/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Palacos R radiopaque bone cement, 40 gram. Product number 424800.

There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.

The firm issued recall letter for one lot dated January 21, 2003, but a subsequent letter dated January 21, 2003 expanded the recall to all lots. Customers are instructed to not use the product. They are to either return it to their local distributor, or to mix the cement and properly dispose of it themselves. [This is a hazardous material requiring special shipping methods.]

StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer

Label may bear an incorrect part number [2227-02-02] and size [03.8MM].

A recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers.

McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.

Labeling mixup.

Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.

Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK

Product has latex free symbol on package, yet contains latex components.

On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.

STA-Compact Hemostasis System with Cap piercing capability.

With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

The firm sent out letters on March 5, 2003 to their customers alerting them to the problem and providing further guidance on how to prevent the problem. The firm will be sending out to the customers a protective device to attach to the needle assembly as soon as possible

Tachos DR - Implantable Cardioverter Defibrillator.

Potential for battery to delivery less than full amount of energy.

The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients. The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.

Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic

The product was shipped prior to being sterilized.

Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement.

Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE

The metal substrate cautery tip may break during use.

On 12/20/2002, all consignees were notified by letter to return all affected product.

Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064

The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values

Recalled by letter dated 3/4/03. The laboratory accounts were informed of the lot of calibrators causing depressed values for the IMx AFP Low Control, requested to destroy any of the suspect lot of calibrators, and recalibrate the AFP assay using a different lot of calibrators.

Femoral Resection Guide, Scorpio L.R.S. Instrumentation.

Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.

Product recall letters and product accountability forms were sent via FedEx to all Branches/sales agents on July 17, 2003. For the Canadian and International customers, the recall notification was also sent on July 17, 2003. All devices are to be returned to Howmedica Osteonics, Mahwah, NJ.

TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.

Instrument fell apart during cleaning prior to surgery.

Firm telephoned customers on 2/7/2003 requesting that they immediately return thier instruments.

Heart-valve, allograft

Donor of aortic valve had procurement cultures that were positive for E-coli.

A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.

Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)

Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.

A recall notification letter was sent via Federal Express to all affected customers on 06/16/2003.

Flexgard, off-the-shelf knee brace, product number 14761106

Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.

The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees if the product was further distributed.

Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108

The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.

On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Nobel Biocare Replace Select Radiographic Template, part number 30159.

Misprinted radiographic template plates. Misprinted labeling.

The firm''s recall notice asks customers to return the template that the customer has in a prepaid envelope for a replacement. The firm is also placing a notice on it''s web based order page so customers can be reminded when ordering.

Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

Product elicits fluorescent signal interference due to contamination.

On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.

Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.

SHPI LIftLoc Safety Infusion Sets

Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.

The single consignee (BAS) was notified by lettter on 4/14/03.

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

Bacterial contamination of the high positive control.

Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.

Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas

ICT assays run using a manual dilution will not be calculated correctly by the software.

Product Information letter dated 29 December 2000 was sent to all AEROSET customers.

BiodivYsio SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.

The medical device is misbranded in that the compliance chart of the Stent diameter may allow overexpansion that may result in vessel damage.

On 7/21/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

Lot gives lower specimen results compared to results generated with other lots.

Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.

Anti-HBs Reagent Kit, list 7C18-25, 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

Particulate matter in the microparticle component.

Abbott affiliates in Canada, Germany and Japan were faxed copies of the recall letter on 4/7/03 for translation where needed and dissemination to their accounts receivin the suspect lot. The end users were advised of the mold-microparticle aggregation and instructed to discontinue use and destroy any of the lot remaining.

ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas

Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.

Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.

Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case

Some of the kits labeled as latex free contain latex gloves which are properly labeled.

Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.

FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01Wesley Jessen Corporation, 333 E. Howard Avenue, Des Plains, IL 60018, USA, Made in USA, Sterile.

Mislabeling

Each customer was sent a recall letter via traceable mail on 12/16/02 with a Business Reply Form and a pre-paid air bill to return the product and completed form was attached. Customers who have not responded in 30 days will be contacted by telephone.

Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile.

There is a potential for package seals to be open after sterilization.

The oldest lot that the firm has confirmed in inventory that had an open seal was manufactured in October 2002. Based upon depletion analysis with distributor inventory being three months and an additional assurance of 12 months, the firm is removing product manufactured from October 1, 2001 through February 28, 2003. Consignees were notified via certified letter with Business Reply Form attached for effectiveness check. Consignees were advised to remove/segregate, and return affected product for credit.

Vacuette, Safety Blood Collection Set with Luer Adapter

The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

Consignees were notified via certified letter on/about 3/6/2003 and were advised to stop distributing the product immediately and to discard any remaining product in stock.

V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.

Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.

Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.

Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

Product mix-up. 16mm stem in a 18mm package.

Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.

10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature.

10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.

Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.

Bed/chair alarm

In some cases the unit appears to be monitoring the patient, when in fact the alarm is silenced.

Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.

Some components have disassociated post-operatively resulting in additional surgery to the patient.

Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.

25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

The wrong product in the box.

The domestic account was contacted via fax on 11/8/02 and 12/10/02. The foreign accounts were contacted via email on 11/5-12/02.

Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.

test results may be inaccurate by 0.2 to 0.5 ng/mL

The recalling firm telephone each customer on 4/24-28/03 to determine if any customer used the lot (CD4085). If so, the customer was instructed to retest all samples with an alternate lot. All customers were instructed to discard any remaining inventory. As a follow up to the phone calls, the recalling firm issued a recall letter dated 4/25/03 informing the customer of the problem and to discard any remaining product.

BD First PICC 3F 65 cm Single Lumen Procedure Kit.

A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.

All distributors and known hospitals were notified on 04/04/2003 by telephone, followed by a fax notification.

Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI.

Wires may break or pull out, causing device to malfunction

The recalling firm telephone the end/prescribed users and distributors. Follow up letters were issued to those that received phone calls. The end/prescribed users'' physicians were also notified via letter.

Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators

Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.

Recalling firm notified foreign distributors and domestic consignees by e-mail and phone on 6/13/2003. Foreign regional distributors were requested to manage the recall. The notification described various instrument problems and remedial action available via the firm''s field action retrofit kits, #6600-0126-850 for the Giraffe OmniBed and #6600-0261-850 for the Giraffe Incubator.

Foundation Knee System, non-porous Femur Size 8, Right

Product container was labeled incorrectly indicating left femur instead of right.

The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.

Access Progesterone Assay, Part number 33550.

Primary tube sampling issue may cause false low results.

Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.

Coulter LH 700 Series Hematology Analyzers

Biohazard situation exists for users.

Customers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.

AcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter

Failure to cycle properly ammong samples.

Customers were sent a letter dated January 20, 2003 that describes this situation and provides modified operating instructions to prevent the occurence.