2012 Product Recalls

Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.

ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.

Micro Therapeutics Inc, dba ev3 Neurovascular performed product recovery according to the following outline. a) Quality Assurance Department (QAD) was used to provide details of product distribution for the affected lots. b) Based on the Health Hazard Assessment, the risk was considered undesirable. c) The affected product was part of a limited market release for Physician Preference Testing. As the product was within control of ev3 employees, no public notification was performed. d) Quality Systems contacted the sales representatives identifying the part number, lot number and number of units sent, and a request to segregate and return the affected product was initiated. e) Product returned to ev3 Neurovascular was held in Restricted Stock pending complete device accountability and disposition. f) The ev3 Neurovascular Quality Assurance department scrapped the affected product. g) The ev3 Neurovascular Regulatory Affairs department was responsible for assuring documentation and appropriate notification to regulatory bodies as required.

ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Concord, CA; Intended to deliver x-ray radiation for therapeutic treatment of cancer. ARTISTE with 16

The potential safety issue with the 160MLC or the HPD collimator of mechanical noises and/or sticking of the collimator when rotating the collimator. The potential for mistreatment to a patient should the collimator not be aligned correctly if the bearings are damaged.

Urgent: Medical Device Correction Safety Advisory Notice letters were sent by certified mail commencing August 3, 2010. The letter described the issue and when it occurs, the measures users could take, and how Siemens would address the issue. It is recommended that customers include a check of the field alignment at 90 and 270 degrees gantry angle in the daily check prior to start of patient treatments. A copy of the Safety Advisory Notice should be included in the Owner's Manual and questions should be directed towards the local Siemens Service Engineer or Application Specialist.

Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants

The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem Elite may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds.

Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of worktime thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.

Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).

These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips.

Alphatec Spine contacted all affected customers via telephone. The communication included discussion of the product, problem, and actions to be taken by the customers. Customers were instructed to remove the affected product from inventory and to return the product to the firm. Arrangements were made for replacement product to be sent to the customers. Contact the firm at 1-800-922-1356 for questions regarding this recall.

NHTSA Jan 30, 2012

SPARE TIRE/FMVSS 110

AN INCORRECT LABEL COULD LEAD TO IMPROPER TIRE INFLATION WHICH COULD RESULT IN A TIRE FAILURE, INCREASING THE RISK OF A CRASH.

HONDA WILL NOTIFY OWNERS, AND DEALERS WILL INSPECT THE SPARE TIRE AND IF NECESSARY, EXCHANGE THE SPARE TIRE ASSEMBLY OR REPLACE THE TIRE INFORMATION PLACARD FREE OF CHARGE. THE SAFETY RECALL BEGAN ON FEBRUARY 10, 2012. OWNERS MAY CONTACT HONDA AT 1-800-999-1009.

Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12,

The firm used alcohol triple swabstick and prep pads manufactured by H & P Industries in the manufacture of their custom dialysis kits. Those swabsticks and pads were subsequently recalled due to possible bacterial contamination.

The firm, Lee Medical International Inc., notified their consignees by email and telephone on August 17, 2011. Consignees were instructed to remove the affected product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers. For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com.

Genzyme Biosurgery Essentials Kit, Item Number 82004

Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.

Genzyme notiifed physicians with the Dear Doctor letter on July 13, 2010 via UPS Ground delivery. The letter informed healthcare workers of the recent incidents and advise them to heed the Essentials Kit label and exercise proper handling of the Kit.. A fax return form will be provided for the physician to sign and return to Genzyme to acknowledge receipt of the notification. Contact Genzyme Medical Information at 800-453-6948, option #3 for any additional information or contact your Genzyme sales representative with any questions.

Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-HEMO-15G, 100/CS,

Firm manufactured custom dialysis kits with Povidone Iodine (PVP) Prep Pads which were recalled by H & P industries. Those pads were subsequently recalled due to possible bacterial contamination.

The firm, Lee Medical International Inc., notified their consignees by email and telephone on 03/22/2011. Consignees were instructed to pull product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers. For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com.

O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3) REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPESSINGLE USE ONLYOriginal design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Aust

O'Neil Sterile Field Intermittent Urinary Catheter Kits With Povidone Iodine Swabsticks are being recalled due to a recall on the Triad Povidone Iodine Swabsticks contained within the kit. H&P Industries are recalling the Triad Povidone Iodine Swabsticks because it was determined that the swabsticks were manufactured without having a system for microbial testing in place at the time of release.

The firm, Go Medical Industries Pty Ltd, sent an e-mail on September 3, 2011 and follow-up with an "URGENT: MEDICAL DEVICE RECALL" letter dated September 07, 2011 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and not sell the product in the market place; immediately perform a sub-recall and notify their customers and complete and return the RETURN RESPONSE FORM via fax at 716-883-8099 or mail to: American Australian Medical Inc, 1083 Delaware Avenue, Buffalo, NY 14209. For further details you can contact QA Manager at Go Medical Industries at +61 89 381 3226 or pmoretta@gomedical.com.au.

GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor

Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering. The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced injection sites and OPTION-LOK MICRODRIP SOLUSET, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 12722-65.

Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

Hospira sent the Urgent Device Recall letters dated 11/25/09 to their direct accounts of the affected products and requested these consignees to notify their customers of the recall. The accounts were informed that Hospira ceased manufacturing the I.V. gravity and pump administration sets with the CAIR clamp manufactured by Borla S.P.A. of Italy in March 2008, due to customer reports related to a difference in the zone of control used to adjust the flow compared to the original CAIR clamp design. To avoid the possibility of flow rate variances, Hospira is recalling all remaining sets with the Borla designed CAIR clamp. The accounts were requested to quarantine all inventory of the affected lots, complete the enclosed reply form indicating the amount of product being returned, fax a copy of the completed form to Stericycle at 1-877-377-5114, and include a copy with the returned goods to Stericycle at 2670 Executive Drive, Suite A, Indianapolis, IN 46241.

Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an in vitro diagnostic reagent for the qualitative identification by light microscopy of human thyroid transcription factor-1 in formalin-fixed, paraffin- embedded tissue by immunohistochemical staining using the automated Bond system; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom; Catalog No.: PA0364

In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the instructions for use.

Leica Microsystems sent Medical Device Field Correction letters dated 7/28/10 to the affected customers via first class mail on the same date, informing them that in combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor types other than is currently indicated on the Instructions for Use. Currently they state that lung and thyroid tumors may stain, but Leicas investigation further characterized the expression of the TTF-1 antigen and it may also be present in other tumors, e.g. thymomas. Customers who have received the affected lot numbers of the three products were requested to refer to the new Instructions for Use to review the amendments made to the Results Expected via the following links: http://bsd.leica-microsystems.com/pdfs/products/ttf-1-ce.pdf; http://bsd.leica-microsystems.com/pdfs/products/ttf-1-l-ce.pdf; and http://bsd.leica-microsystems.com/pdfs/products/pa0364.pdf; The accounts were asked to complete the attached Acknowledgement Form, acknowledging the receipt and understanding of the letter, listing the lot numbers of the units at their facility and fax it back to Leica at 1-847-607-3147. Additional questions should be addressed to the firm's office of Regulatory Affairs and Quality Assurance.

Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP 60 drops/mL; a sterile single patient use Rx device; Hospira Inc, Lake Forest, IL USA. made in Costa Rice; product number 160000401, list number 16000-01.

Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.

Hospira, Inc. issued an "Important Administration Set Information" letter dated November 24, 2009 to their direct accounts, informing them of the affected product. Consignees were instructed to return the defective product to the firm. For further information, contact Hospira Medical Communications at 1-800-615-0187.

Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic.

The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.

Abbott Molecular sent Field Correction Letter/Urgent Field Safety Notice letters dated 1/21/10 to the Paraffin Pretreatment Regent Kit customers on 1/22/10, informing them that the MSDA symbology for hazardous and corrosive material is missing from the Paraffin Pretreatment Regent Kit II and Paraffin Pretreatment Regent Kit III labels. The information is missing from the vial label, kit label and package insert. The letter listed the risk and safety statements that should be included in the package insert, and advised the customers should use the kits in accordance with the listed risk and safety statements. The accounts were instructed to review this information with laboratory personnel and retain the letter for future reference, making copies of the letter and placing them in each kit in stock. Any questions were directed to their local Abbott Molecular Representative. Abbott Molecular plans to telephone each customer to ensure that they have received the letter and have disseminated the information to their laboratory personnel.