Recall Z-2083-2009 ยท CAZ Anesthesia Conduction Kit
Integra Life Sciences Corporation
Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378, 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.
| Date | Sep 21, 2009 (initiated Jul 13, 2009) |
| Status | Terminated |
| Reason | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. |
| Root 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 | 150 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. |
| FDA record | Open on fda.gov |