FDA Device Recalls in 2003
213 recalls found
December 2003
EBI VueCath Endoscopic Spinal System
Non sterile device is labeled sterile.
The firm notified their customers via a field correction letter dated June 17, 2003. Instructions given are to sterilize the unit prior to use. A EBI field representative will be visiting to replace the boxes.
Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
Kits had parts in them that did not belong in the kit.
Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.
Alpha Mirage Top Tightening Spinal System 5.5 mm x 45 mm Length Bone Screws
Laser marking is wrong on bone screws, says 40 and is 45 mm long.
Customers were notified by fax in a letter dated May 19, 2003. All customers have been notified.
TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
Hill-Rom Newborn bassinet; model P247
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
Customer notification letters dated June 20, 2003 were sent to each customer. Customers are asked to verify the security of the casters to the base and to visually check for loose or missing caster screws, to remove any bassinets from service until repaired, and that Hill-Rom will visit each customer to replace the caster screws on all units.
Fix pins associated with Stealth Station Treatment Guidance Platform
Surgical devices intended for single use were not labeled for single use.
Consignees were notified by letter on 11/01/2003.
DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
Lacks professional use labeling and firm name and address.
Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.
TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds
Battery Failure/ Outgassing
Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
Product may not be sterile.
Distributor was notified via email on 6/11/2003 and advised to quarantine the product. A follow up letter was sent via certified mail to the distributor and to the contract packer on 6/18/2003 with a questionnaire and a self addressed stamped envelope to verify effectiveness.
Model LightLas 532 Opthalmic Photocoagulator Laser
Firm needed to include calibration procedures in user guide.
Firm fedexed new user manuals with calibration procedures to each consignee on 11/11/2003.
Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form.
BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***
The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
The recalling firm notified consignees by Customer Technical Bulletin on 5/21/03 and additionally by 'URGENT MEDICAL DEVICE CORRECTION LETTER' on 10/31/03. The notifications caution consignees about the need to fully understand scaling functionality and to check scaling for every treatment plan. The notification further explains that the next software release will be modified to include a screen message that appears whenever automatic magnification appears.
Block Mold Cutter, Model 8532, Version 1.2.
The units lacked the required labels per the laser performace standard.
ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Complaints were reported of difficulty in stent deployment.
Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement.
Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.
CryoValve Pulmonary Valve & Conduit.
Microorganisms detected in associated allografts.
The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.
Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.
Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.
Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers. An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.
Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm.
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
The firm contacted their customers by FedEx on 5/21/2003.
Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
May have incorrectly printed graduation markings along the tube shaft.
A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.
COBAS TaqMan analyzer, Series 96; catalog number 8080216.
A false positive result may be reported.
Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted.
Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied.
APSOF-7-4-RB, ZIMMON PANCREATIC STENT W/RADIOPAQUE BANDS, Stent Diameter: 7 FR., Length (Between Curl and Flap): 4 CM, For Use With Wilson-Cook Stent Introduction System: 7 FR. Minimum Accessory Channel Size: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
The label is missing the Rx Only symbol.
The consignee was notified by the sales representative on/about July 29, 2003 via hand delivered letter. The consignee was informed of the recall and was advised to quarantine and return the affected product, via the Territory Manager. The consignee was urged to complete and return the response portion of the letter.
EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.
There is a possibility that the affected devices would not capture a biopsy during a procedure.
On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.
Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers . Cat. No. 6418-26-02.
Compression test results are not in accordance with device approval submission
Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035
The device has the potential for tip breakage during use.
On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
TC-PLUS Solution Tibial Component-- Symmetric
Labeling/packaging mix-up.
Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.
UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
Package integrity not validated. Sterility not assured.
Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.
Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
The product labeled as sterile had not been through its sterilzation cycle.
Recalled by letter dated 1/22/03. The accounts were informed of the non-sterile product, requested to examine their inventories for the affected lot, to return any product found for credit and to sub-recall the product from their customers.
Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005
Brochures approved for international distribution only were distributed domestically.
The firm began to contact all US distributors on October 31, 2002 and all US sales representatives on November 1, 2002, by e-mail to inititate an examination of all pertinent professional labeling in their stock, and request return of incorrect labeling. The firm initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal
Literature approved for international distribution only was distributed domestically.
The firm began to contact all US distributors on October 31, 2002, and all US sales representatives on November 1, 2002, by e-mail to initiate an examination of all Ascension MCP professional labeling in their stock, and request return of incorrect labeling. The firm additionally, initiated a program of telephone contact with all US distributors and sales representatives regarding this label examination request.
UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
Angiographic catheter tips may separate during use.
All 7 consignees were contacted by their sales representatives on 11/5-7/2003.
Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.
The component was manufactured with an insufficient weld that could break during use.
The firm contacted their accounts by email and telephone on 2/26/2003.
Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Patient images may be incorrectly stored in the archive directory of a different patient.
The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.
November 2003
AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA
Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.
Consignees were provided with assay parameters for the RCD flag which may enhance the detection of these type of specimens. The assay parameter settings for the RCD flag were distributed to all AEROSET consignees in the United States by direct mail and to country managers worldwide via a Product Information letter dated July 31, 2002. Also provided with the Product Information letter was an AEROSET IgM Application Sheet containing the updated assay parameters for the RCD flag.
URO PRO Plus Digital Urology Imaging System
X-ray tube arm and collimator fell and fractured patient's ribs.
An initial safety alert was sent to sites on 7/29/2003 to pre-announce repairs and advise them to not use the equipment. A second safety alert was sent on 8/11/03 to confirm repair dates. Repairs were completed 8/19,2003.
Reusable Catheter Passer (40 cm) SP01. One stainless steel catheter passer with T handle.
mislabeled as sterile
The recalling firm issued recall letters to their direct accounts via fax on 9/9/03. The letter informed the accounts of the problem and the need to sterilize the product or return it for replacements.
ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.
100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102
Mislabeled with wrong drop size drip chamber specification.
The firm called and sent fax recall letters on or about 10/30/2003. Labels were shipped and applied to stock in question. Recall is complete.
Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Field Representatives were notified via Fax or E-mail in August/September, 2002. After being notified about the recall, field representatives were responsible for notifying facilities about the market withdrawal and for furnishing instructions for returning products for credit.
Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, LARGE. REORDER NO. 8843. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case. Firm on Label: Allegiance Healthcare Corporation McGraw Park, IL 60085 USA. Allegiance, a Cardinal Health company. Made in Malaysia.
FDA's analysis revealed defects (holes) in the latex gloves.
Recall letters were faxed to the 5 end users on 6/27/03. This was followed up with phone calls to the 5 end users. Recall letters were faxed and mailed to all 18 end users on 7/10/03, advising them of the recall expansion.
Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator. GLU slides are processed by high volume chemistry systems typically used in hospital laboratories.
GLU Slides: Letters dated between 7/28/03 and 8/11/03 provide revised storage instructions. Customers using NaF/KOx blood collection tubes and have VITROS GLU slides that have been refrigerated for more than four months will receive replacement product. Those customers are instructed to continue to use the slides only until replacement product arrives. GLU DT Slides: Letters dated between 7/28/03 and 8/11/03 with the same instructions as for GLU slides.
Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.
Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.
All consignees were notified by letter on 06/13/2003.
AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0)
AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%
All AxSYM AFP customers were informed not to use the 1:101 automated dilution protocol via Device Correction letter dated 6/12/03. If necessary, manually dilute samples per the AxSYM AFP package insert.
Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)
Overinfusion due to misassembly.
Recall letter was sent to sole distributor, B Braun FRance by email on 3/18/2003. Return of stock and subrecall was requested. Consignee has acknowledged implementing subrecall.
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
The irrigation set was mislabeled with the wrong delivery rate of 8 drops/mL when it actually has a delivery rate of 11 drops/mL
Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit.
Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
Product's outer carton label was labeled with an extended expiration date
PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned.
Becton Dickinson's ProbeTec (tm) ET Instrument
Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.
MagNA Pure LC Instrument; Catalog number 2236931.
A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
An urgent product correction letter dated 6/26/03 was sent to each customer advising them not to use DNA protocols until the software update has been installed.