Recall Z-1635-2008 ยท FMF Syringe, Piston
Integra Pain Management
Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
| Date | Aug 14, 2008 (initiated Mar 18, 2008) |
| Status | Terminated |
| Reason | Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin. |
| Root cause | Nonconforming Material/Component |
| Action | Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition. |
| Quantity | 500 kits |
| Distribution | CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960248 | GENERAL PROCEDURE KIT Physician Industries, Inc., Apr 12, 1996 |