2012 Product Recalls

Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as pre

Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.

Lin-Zhi sent a letter via e-mail dated September 8, 2011 to customers with information regarding the recall. The e-mail identified the product description, lot number, description of nonconformity and corrective actions to be taken. Each customer and distributor was then contacted by regulatory affairs personnel by phone on September 9, 2011 or September 12, 2011. Customers and distributors were contacted to determined whether they wanted a replacement of the affected product. Customers that wished for replacements of the affected product was asked to correctly dispose of the product with the lot numbers listed. For questions or concern call 408-732-3856.

Puritan Bennett 840 Series Ventilator Power Supply Model/Catalog Numbers: 4-076314-00; 4-076314-SP

Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.

Recall is by letter sent Fedex 4/20/05. After two weeks nonrespondants will be telephoned. Foreign customers will be handled by firm''s local offices similarly.

AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.

High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.

The firm issued Product Recall letters dated February 22, 2008, requesting remaining units of the affected product be discontinue using and destroyed. A Customer Reply Immediate Action Required letter was enclosed to indicate acknowledging receipt of the product recall letter and to provide information on the number of kits destroyed before March 7, 2008 and faxed to 1-800-777-0051.

***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lberica S.L.WTC Almeda Park, Ed, 1 Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain***Phone +34 934-705-500; Fax +34 933-717-849. Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teet

Biomet 3i is recalling their product Osseotite NT Certain Dental Implant INT411 . The internal thread was not manufactured correctly.

Biomet 3i, LLC sent an Urgent Medical Device Recall letter dated March 14, 2011, via email or fax to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A small percentage of the implant lots may have a condition affecting the internal thread. The condition, if present, will prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from engaging the implant. Customers were instructed to contact Customer Service at 1-800-342-5454 if this condition is recognized upon attempting to assemble any of the screws with the implant. Customers were instructed to return the implant to the firm for replacement to the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CC117886 Customers were also instructed to respond with the attached Response Fax or email to DomesticComplaints@Biomet.com. For any questions regarding this recall call 561-776-6906.

Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection.

Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient.

Spacelabs Healthcare, Llc sent an "Urgent-Medical Device Correction" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments. Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304.

Precision Implantable Pulse Generator (IPG), Model Number SC-110

Mislabeled: Product labeled with the incorrect shelf-life information.

There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.

AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30

False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.

Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.

Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.

A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units.

ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1

This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical procedure. Pneumoperitoneum leaks may lead to conversion from laparoscopic to open surgery.

Ethicon Endo-Surgery sent an URGENT: DEVICE RECALL EVENT 2244 letter, dated October 8, 2010. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to stop using the product, examine all inventory to determine if they had the affected product on hand, and remove the affected products from inventory. Ethicon Endo-Surgery requested that each customer complete the Business Reply Form and fax it back to Stericycle at (877) 272-6141 with in 3 business days and also return any affected product to Stericycle. For question regarding this recall call (877) 598-5706 and reference 2244.

Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Module, Model M5529A. The HeartStart MRx portable external defibrillator has optional accessories which include a wall mount and a DC power module. The wall mount is intended for storage and transport of MRx devices in land based transport vehicles. The power module is an additional optional accessory intended to be connected to the wall mount as a means for charging MRx devices (batteries) when stored in the

HeartStart Vehicle Wall Mount (Model M5528A) with DC Power Module (Model M5529A)--Incorrect wiring during installation by user may result in a smoke or fire hazard.

Philips Healthcare, Inc. notified customers by an "URGENT - Voluntary Medical Device Correction" letter, plus revised Instructions For Use (IFU) for the Vehicle Wall Mount accessory and the DC Power Module accessory of the HeartStart MRx which includes a revised description of correct installation and verification of performance. Customers were asked to follow the Actions in the customer/user section of the Urgent - Voluntary Medical Device Correction Notification. In this section, customers were given the instructions to correct their devices. Distribution of the Urgent - Voluntary Medical Device Correction Notification along with the IFU will be managed by Philips representatives in each affected geography. Direct questions or concerns about the recall to your local Philips representative.

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, S

Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.

Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.

FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).

Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured.

On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989-7373, extension 3234 or 1-51 3-71 9-3234 for recall instructions. Representatives will be available to take your call from 8:30 a.m. until 4:30 p.m. eastern standard time, Monday through Friday.

Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085.

Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators.

Lin -Zhi International sent a Recall letter dated October 11, 2011, and a e-mail to all affected customers. This was followed up by a personal phone call from Lin-Zhi personnel. The letter identified the product the problem and the action needed to be taken by the customer. The customer will be contacted to determine whether or not they were affected by this non-conformity. If they have been affected, they will be offered replacement Multi-Analyte Urine Intermediate Calibrators which are currently estimated to have a four week wait time before they become available. For further questions please call (408) 732-3856.

Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.

Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings.

The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.

LIFTGATE BATTERY BOX MOUNTING

BATTERY BOXES MOUNTED WITH THE INCORRECT SIZE OR IMPROPERLY ORIENTED MOUNTING PLATES CAN BECOME DETACHED FROM THE TRAILER, INCREASING THE RISK OF A CRASH.

UTILITY WILL NOTIFY OWNERS AND DEALERS WILL INSPECT THE MOUNTING PLATES AND REPLACE THEM AS NECESSARY, FREE OF CHARGE. OWNER NOTIFICATION HAS ALREADY BEGUN. OWNERS MAY CONTACT UTILITY TRAILER MANUFACTURING COMPANY AT 1-626-854-7215.

Super Luchamania Action Figures Recalled for Poisoning Hazard

The surface paints on the action figures contain excessive levels of lead which is prohibited under federal law.

Consumers should immediately take the recalled action figures away from children and return them to Lee Carter Co. for a full refund or credit towards a replacement product.

Infant Rattles Recalled for Choking Hazard

The rattle's handle is small enough to fit into a child's throat, posing a choking hazard and violating federal rattle standards.

Consumers should immediately take the recalled rattles away from infants and return them to Lee Carter Co. for a full refund or credit towards a replacement product.

Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhesive Kit ADVANCED BIONICS CORP 12740 San Fernando Rd. Sylmar, CA 91342 USA. The Precision Spinal Cord Stimulator System (Precision System) is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with

Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on

In the United States, notification will be sent to patients with the affected devices. Additionally, their physicians on record will be provided with the notification. The Company is currently planning to initiate this field action on September 22, 2008. The U.S. notification will be sent via Fed Ex or U.S. Postal Service certified mail. The letter advises that Boston Scientific Neuromodulation is voluntarily recalling its first generation charging device, Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System. The Charger 1.0 devices are being recalled and will be replaced with the new second generation Precision Charger 2.0 (SC-5312, currently in distribution) that features a temperature limiter for improved temperature management. The Charger 1.0 can be used until replacement with Charger 2.0 by following the instructions on Page 2 of the letter. Customers are asked to complete the acknowledgement form at the end of the letter and return it to Boston Scientific in the return envelope provided. A representative from Boston Scientific will contact them upon receiving the completed form to schedule an in-person visit at their physician's office to exchange the device. Contact Boston Scientific Technical Serives at (866) 566-8913 for assistance.

Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100

Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.

TRANSMISSION PARKING LOCK

IF THE DRIVER BELIEVES THAT THE TRANSMISSION IS IN PARK AND DOES NOT USE THE PARKING BRAKE, THE VEHICLE COULD ROLL AWAY AFTER EXITING THE VEHICLE INCREASING THE RISK OF A CRASH OR INJURY.

BMW WILL NOTIFY OWNERS, AND DEALERS WILL REPLACE THE AUTOMATIC TRANSMISSION FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 2, 2012. OWNERS MAY CONTACT BMW CUSTOMER RELATIONS AND SERVICES AT 1-800-525-7417.