Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030, 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.
- Recall Initiated
- July 13, 2009
- Posted
- September 21, 2009
- Terminated
- October 23, 2009
- Recall Number
- Z-2084-2009
- Quantity
- 44 units
- Firm Location
- Salt Lake City, UT
Reason for Recall
Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
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.
Lot / Code Info
Lot number W0905239
Root Cause
Packaging process control
Action Taken
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.
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