FDA Recalls in 2003
213 recalls found
July 2003
LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645
Incorrect Hemoglobin result can be reported with software version 2A and higher.
Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.
A.R.C. Laser Photolysis Probe/Handpiece
Product may not have been properly sterilized.
The 5 consignees were notified by phone on 06/06/2003, followed by fax and letter notification on 06/10/2003.
Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is a Member of SSL International plc. Lot Number 01H0161 through 01H2668, sizes: 7-7 , One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case.
Sulfur particles on the surface of gloves.
On 11/25/2002 the Company representatives contacted the headquarter offices of the firm's in the U.S. by telephone and in writing by UPS delivery. On 11/26/2002 the Company sent the distributors' branches letters via UPS delivery. Approximately 1500 hospitals (customers of the Company's distributors) were notified by letter via UPS delivery. Customers were instructed to cease distribution of the suspected lot number gloves, contact their customers, and return any remaining gloves via UPS to the recalling firm. A response letter is attached to the recall letter. The Company intends to contact by telephone all of its direct accounts who do not respond to the Recall Letter.
Inject 10 Coronary Control Syringe (CCS), 10ml
Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.
On 5/16/2003, all distributors and consignees were notified by letter.
CryoValve Allograft, heart valve
Microorganisms were detected in distributed donor tissue.
Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.
Roche/Hitachi Tina-quant RF II; catalog # 3004902
Test results may exhibit a positive bias when plasma samples are used for the assay.
A reagent bulletin dated 9/30/02 was sent to all users. Customers were instructed to discontinue the use of plasma samples with this reagent.
COULTER LH 700 Series Hematology Analyzers
Software vote out logic changed. Erroneous white blood cell counts.
Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.
CryoValve Allograft, Pulmonary Heart valve & Conduit.
Microorganisms were detected in associated allografts after initial release of donor.
The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003.
Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
In Vitro diagnostic test kit may produce false positive patient results
The firm notified consignees by phone and fax 2/7/03 and advised of potential for false positive patient results. Firms were instructed to destroy remaining inventory for replacement. Consignees were asked to return response form.
CryoValve Allograft, Heart valve
Microorganisms were detected in distributed allografts.
CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.
CryoValve Allograft heart valve
An allograft associated with this donor has been linked to an alleged infection.
A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. The allograft SID 72552025 (V00) was located in storage at the SUNY University Hospital, Syracuse, NY. The CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction.
ProLong Continuous Nerve Block Set model nubers PL-50 and PL-100
Catheter does not fit through the needle resulting in delay of medical procedure
The firm initiated the recall via letter to all consignees on May 9, 2001.
CryoValve Allograft, Aortic Valve & Conduit
Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.
The hospital was notified by letter on 5/05/2003.
SKBM Microkeratome cutting tool
Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.
Customers have been notified in writing of this recall action (11/18/2002), and instructed to return all SKBM and/or Lasitome microkeratome products. All returned product will be physically segregated and dispositioned by Alcon. Recall Effectiveness checks will be attempted between 10%-100% of the consignees.
TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.
Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.
All consignees were contacted by telephone on 05/09/2003, followed by a letter.
Stryker brand Neptune waste management system; model 711-27-1.
Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
Each account was contacted by phone, beginning on December 3, 2002 and advised to refrain from using the units until repairs could be performed. A recall notification letter dated December 6, 2002 was sent to each account informing them of the recall and of plans for repairs.
DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box.
Non-sterile surgical medical device is labeled as sterile product.
Recalling firm notified consignees by certified mail 2/25/03 and advised to immediately cease using or distributing product. Distributors were requested to further notify their consignees or provide customer contacts. Consignees requested to return response form for replacement product.
Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.
Stitching in wheelchair seat back is defective and may not support user.
Firm notified dealers and sales representatives by certified letter on 2/25/03. Dealers were requested to phone the company for replacement options. Sales representatives were advised of the stitching failure via an 'urgent product recall' letter and instructed to immediately cease use and distribution, and further notify customers. Reps were asked to collect all recalled parts WPHS from consignees they have identified and return with response form.
June 2003
Misys Laboratory versions 5.23 and 5.3
Software anomally.
A recall notice along witn instructions for avoiding conditions that might cause the observed anomalous results was faxed to all customers 11/22/2002.
OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses.
Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.
Elecsys Troponin T; catalog number 2017644
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.
Stryker Secure II hospital bed; model 3002.
A wire may break at the crimp and present a potential electric shock hazard.
The firm sent service representatives to the receiving hospitals, beginning on 5/1/02, and the beds were corrected in place.
Sarns MP4 Cardioplegia Sets; catalog number 15501.
There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
Initial customers were notified by telephone beginning on February 25, 2003. A follow-up recall letter dated February 27, 2003 was sent to each customer. Wholesalers were requested to either contact their customers or to provide their customer information to Terumo so that Terumo could notify the customers.
ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set.
Sterility may be compromised
On 1/21/03 the firm notified, via telephone, the distributor of the product. The distributor was advised to return any unused product and to contact their customers for return of product. This was followed by a letter 1/21/03 sent via e-mail. The distributor in turn contacted their customers on 1/23/03 by telephone. This was followed by a letter dated 1/23/03.
Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
Label printing irregularities on cartons and/or bottles.
Letters dated 1/10/03 sent U.S. Mail instructing customers to examine inventory and discard bottles or cartons with missing or illegible print.
May 2003
Surgical Mesh
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent to each consignee.
Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.
Surgisis peripheral vascular patch; catalog number C-VSLH-4S-1x10.
Adverse events- suspected pseudoaneurysm
The remaining stocks were picked up at the hospital consignees on December 13 and 17, 2002.
N/A
Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
A recall letter was sent to the consignees on January 8, 2002 and requested the return of the product.
Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.
All customers were nofitied by phone and letter. The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003.
Gamma Drill 5.5x300mm
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.
CryoValve Heart-valve, allograft
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
Implanting physicians were notified by letter on 3/19/2003. Since CryoLife has been notified that the allografts have been implanted, the notification is intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. They were advised to complete an enclosed, stamped, self-addressed postcard to affirm receipt of the notification.
Chlamydia OIA. For in vitro diagnostic use,
Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.
Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267
Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.
Becton Dickinson notified distributors by fax on 11/18/02 to discard inventory. Firm additionally notified distributors on 11/21/02 to include three additional lots of agar for recall. End users were notified by letter 11/21/02 to discard inventory for replacement, and return reply form.
Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon
Medtronic AVE notified the two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped.
FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).
FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.
Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement.
April 2003
ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only
Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
The recall notification was faxed to all 54 consignees on 12/8/02. A follow-up hard copy of the recall notification was sent via FedEx on 12/9/02.
Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Lot 1170119, Expiration 2007/10, BC 8.9, DIA 13.8, SPH -1.50, CIBA Vision, Corp, Duluth, GA 30097, Made in USA.
Lenses were labeled with the wrong prescription.
In the United States, CIBA Vision contacted accounts via traceable letter on 11/12/2002 with attached Business Reply Card form.
BD K-3000 Microkeratome Blade REF 378607
Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form.
Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System.
Cleaning agent residue from packaging material was adhering to implantable hip stems.
Consignees were notified on 12/26/2002 via telephone and e-mail.
Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K
Catheter shaft has potential to crack during use.
On 2/21/03 the firm initiated the recall and its notification was via letters to inform its consignees about the problem with its catheters. It requests immediate discontinuance of all product with certain lot numbers.
''ComforTEC II Single Use pH Probe *** Latex Free *** Do Not Re-use''. Packaged individually.
Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
All consignees were notified by letter on 01/08/2003.
SurgiFrost Cryosurgical Probes
Device design failure, connectivity.
This recall has been completed. Recall notice was sent by fax on October 25, 2002.
CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
Letters dated 12/18/02 with instructions to inspect inventory and to discard affected product.
AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
Reports of needle fixed-tip electrodes becoming loose or breaking off.
All consignees will be notified by phone or visit beginning 01/15/2003.
One heart and pericardium from donor 12144.
Human tissue was procured from donor using non-sterile instruments.
Consignee was notified by memorandum on 8/20/2002.
Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.
The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.
The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.
Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis) Catalog No. 6265-5116
Hip Stem Fractures in the neck area.
Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.