FDA Recalls in 2006

Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.

Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two - 6 oz. bottles of TruRepair Powder; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 092160

The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up.

Customers were notified by telephone calls on 9/23/04. The accounts were informed of the mix-up with the liquids and were requested to return the kits for replacement.

Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; catalog 0921885,

The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.

Bosworth initiated a recall of the trays by undated letter on 10/13/04 sent to all of their customers. The letters informed the accounts that the Tray Away #3 did not meet their standards, and requested the accounts to return all of the Tray Away #3 trays in stock for replacement. Follow-up letters dated 12/26/04 were sent to the consignees, requesting a response to the notification, indicating the amount of product being returned to Bosworth.

Tachos DR - Implantable Cardioverter Defibrillator

Potential for device to not deliver full amount of energy

On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.

Compounding Brochure titled ''Nutrition Compounding Simplified'', Lit #800415, print date January 2002; the brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High Speed Compounder System, product 2M8077, the Automix 3+3 Compounder System, product 2M8286, the Automix 3+3 Compounder with Accusource Monitoring System, product 2M8287, the Micromix Compounder System, 1.0 mL, product 2M8290, and the Micromix Compounder System, 0.3 mL, product 2M8290L;

The promotional material for the Automix/Accusource and Micromix compounders and Micromix Compounder Implementation Guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.

Baxter sent Important Product Information letters dated 4/30/04 to all of the compounder customers, informing them of the inaccurate information and requesting that the Nutrition Compounding Simplified brochure, Baxter Info Quick Cards on CD-Rom, versions Q4 2003 and Q2 2003, and pages 60 and 61 of the Micromix Compounder Implementation Guide be destroyed. Replacement pages 60 and 61 of the implementation guide were enclosed with the letter. The letters also listed the accuracy information for each compounder based on Baxter''s supporting data, as well as the specific information regarding the overdelivery alarm limits referenced in the Operator''s Manuals.

Agfa Cronex 10T Radiographic film

Mislabeling; Product labeled Cronex 10T actually contains Afga, Curix Ultra UVL Plus.

Consignees were first contact by telephone followed up with a certified letter, on/about 12/21/2005.

Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.

Inaccurate test results. The magnesium values for the A31/A41 Gemcal Serum calibrator gave control results that were biased approx. 20% high.

Field correction letters were sent to the firm's customers via FAX on 1/14/2006-1/17/2006 and via UPS on 1/17/2006-1/19/2006. An updated letter was sent out via FAX on 1/27,30,31/2006 and via UPS on 1/30/2006 and 2/1/2006.

''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3

When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens

On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthc

Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.

Recall letters dated 11/15/02 were sent via 2-day FedEx to the direct accounts. The accounts were informed of the potential for breakage of the catheters during use, requested to inspect their inventories for the affected lot numbers, and segregate any found for return to Allegiance for replacement. Distributors were requested to sub-recall the product from their accounts. The recall was extended to include the 21 additional lots by letter dated 4/8/04. The letters were sent via Airborne Express, 1-Day, on 4/8/04. The instructions were the same as the 11/15/02 letter, except that Allegiance has changed their name to Cardinal Health.

Baxter Posiflow Access Device for IV Access; product code 2N9050; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL; Baxter Healthcare Corp., Deerfield, IL 60015 USA; the Posiflow Access Device is manufactured for Baxter Healthcare Corporation by Becton Dickinson

Product older than three years may not operate as intended.

Urgent Product Recall letters dated 1/20/05 were sent to the direct accounts via first class mail, to the attention of the Director of Purchasing. The accounts were informed that the Posiflow Luer Activated valves may not operate as intended if the product is older than three years. The accounts were instructed to examine their inventories of the affected product codes listed to determine if they have any product on hand without expiration dating, and remove any found from inventory. The expiration date, if present, may be found on both the individual product package and on the end panel label of the product shipping carton. The accounts were instructed to call Baxter at 1-888-229-0001 to arrange for the return of any product found without an expiration date. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler

A problem in the software has the potential to be associated with the incorrect reporting of sample results.

On 7/22/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the corrective action.

Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216, 194-5223

The device was producing false negative results for cocaine tests.

Phone calls and faxed notification forms were sent to all customers on June 4, 2004. Outside the US, subsidiaries were notified via e-mail with forms to be completed.

ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.

Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).

BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.

CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer

T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.

The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191.

The brushes may experience head breakage when insufficently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.

The recalling firm sent a recall letter dated 2/23/05 and dated 3/4/05.

AccessAED (without audio record) Model Number: 9100-0100-0

Device may fail to deliver shock due to a faulty circuit board

AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation.

Clintec Micromix Compounder, an I.V. solution compounder; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy

The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted

Baxter began telephoning their customers on 4/26/04, advising them that an improperly adjusted Vlier pin could result in an ingredient delivery outside of stated accuracy limits. The accounts were requested to immediately stop using the Micromix Compounder and return the device to Baxter, and to evaluate all TPN formualtions that have been compounded but not administered to determine if any ingredients were delivered at a programmed volume of less than 1 mL. The account was advised to discard those solutions and recompound them using manual techniques. Follow-up recall letters were faxed to the accounts on the same date, reiterating the telephone calls. Baxter sent second recall letters dated 2/16/05 to the 15 customers who had not yet returned their Micromix Compounder as of 2/16/05, along with a copy of the 4/26/04 recall letter. The customers were informed of the new issue with the Micromix Compounder not recognizing decimal points for delivery volumes below 1 mL, and were again requested to return the Micromix Compounder and the handheld keypad to Baxter so that they may be corrected when the Micromix is reintroduced the market.

Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

Consignees were notified via letter dated 12/9/05.

Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-7.0-40.

The side of the box gives the size of the stent as 10 x 40 instead of the actual size of 7 x 40. The label front is correct.

Consignees were notified of the initial recall by phone beginning on 10/24/05 and of the extension to the second product on 01/06 /06.

Roche brand Elecsys Troponin T; catalog number 2017644.

A false negative result may be reported.

Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.

Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40.

The side of the boxes give incorrect sizes for these stents. The label front is correct.

Consignees were notified via telephone on 1/26/06 and a follow-up fax was sent.

SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery.

When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Underestimates percentage of stenosis, false negative result.

On October 26, 2005, the company sent their customers a User Guide Addendum that told customers how to verify that the image calibration data was correct.

Ultraview Universal Clinical Workstation Model 90385.

Potential for telemetry channels to drop off display.

For all US customers, a Medical Device Correction letter was mailed on May 7, 2004 via courier instructing their customers to insure all monitored patients are displayed. The letter also instructed customers to move the printer to another central monitor as well as having a Field Service Engineer install new software when it becomes available. This letter was also mailed to international customers on May 14, 2004.

Zimmer Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.

The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

Consignees were notified by letter on 02/11/2005.

Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.

Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.

BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA***

A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.

The recalling firm notified consignees by phone, fax and e-mail on 12/01/05. The notification advised that nephelometers displaying 'CAL' error messages on the LED should not be used until calibrated with a different kit lot. Consignees were requested to discard referenced lots for replacement. A response form was included in the notification.

AxiEM EM Knee Kit, and associated workstation.

Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

Medtronic field personnel were notified by letter on 02/01/2006 and instructed to immediately contact each affected site and schedule an upgrade with the revised firmware

EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.

The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.

Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.

Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.

Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.

Tecan US notified consignees by registered letter on/about 3/13/2003. International accounts were notified via e-mail 3/13/2003 by Tecan Switzerland. Consignees were advised to contact the firm''s Technical Support line to coordinate the PosID firmware upgrade.

Bard PEG Safety System ''Guidewire'' Reorder Number: 000930

Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile

Bard Endoscopic notified customerson 8/4/03, by Recall Notice sent by registered mail, along with an Effectivity Form that each Bard account will complete and return. Product will be returned to Bard Endoscopic. 5. The BET Recall Coordinator will track effectivity, and phone accounts that have either not returned the Effectivity Form or whose letter had been returned as undeliverable.

Meridian PA Femoral Stem

The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.

Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103.

Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left.

Firm''s sales representatives were notified via email on 2/22/06 to visit the customers, remove the product from inventory, and to return it to the firm.

SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable

The dilator size does not match the label on the product and product packaging.

A recall letter was issued to the consignees on 1/5/06 requesting return of the product. The letter also requested a sub-recall if the product had been further distributed.

CryoValve, Pulmonary Valve & Conduit

Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.

Physicians were notified by letter on 1/27/2006.

HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134

A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

On 9/7/05, the firm issued letters via Federal Express and telephone follow-up to all its consignees, informing them of the affected product and providing instructions on the recall.

Sollux Systeme commercial tanning beds; Soleil Systems, Inc. The following models are affected by this recall: a) Sollux Systeme 32 - 32 x 100 w tanning bulbs, no facial tanner bulbs b) Sollux Systeme 32.3 - 32 x 100 w tanning bulbs, plus 3 x 400 w facial tanner bulbs c) Sollux Systeme 36 - 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, no facial tanner bulbs d) Sollux Systeme 36.3 - 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, plus 3 x 400 w facial tanner bulb

The sunlamp products failed to incorporate a timer system and a control for termination of radiation emission in accordance with the Federal Sunlamp Product Performance Standard.

Soleil Systems sent recall notification letters dated 6/28/04 to their dealers on 8/2/04, informing them of the noncompliances of failing to incorporate a permanently mounted timer and on/off switch in the sunbeds. Soleil will bring each sunbed into compliance and requested the dealers to review their sales records for any Sollux beds received between 4/28/04 and 11/01/03, and supply Soleil with a list of names and addresses of end users who received those units. Soleil sent out end user notifications dated 8/20/04 beginning on 8/23/04 and initiated the retrofit of the sunbeds on 10/25/04.

ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA

False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.