Class 2 Device Recall GENERAL PROCEDURE KIT

• Date Initiated by Firm: July 13, 2009
• Date Posted: September 21, 2009
• Recall Status: Terminated on October 23, 2009
• Recall Number: Z-2091-2009
• Recall Event ID: 52683
• 510(K)Number: K945484 K960248
• Product Classification: Syringe, piston - Product Code CAZ
• Product: Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), Disposable, Convenience Kit, Reorder Number PITRW2035, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures.
• Code Information: Lot number W0905067
• Recalling Firm/ Manufacturer: Integra Life Sciences Corporation; 3395 W 1820 S; Salt Lake City UT 84104-4921
• For Additional Information Contact: 801-886-9505
• Manufacturer Reason for Recall: Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
• FDA Determined Cause: Packaging process control
• Action: Consignees were notified by telephone on July 09, 2009 and by "Urgent Medical Device Recall" letter on July 13, 2009. Customers were instructed to immediately examine inventory, cease use and distribution of any affected product and to contact Integra Pain Management Customer Service by calling 1-800-241-2210 to arrange for return and replacement. Refer questions to Integra Pain Management by calling 1-800-241-2210.
• Quantity in Commerce: 680 units
• Distribution: Worldwide Distribution -- US (states of AK, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IN, KY, ME, MO, NC, NJ, NV, NY, OH, OK, PA, RI, SD, ST, TX and UT), Belgium and Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAZ; 510(K)s with Product Code = CAZ