Recall Z-2575-2011 ยท FMF Syringe, Piston
Integra LifeSciences Corp.
Integra Pain Management Disposable, Convenience Kit PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
| Date | Jun 22, 2011 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | Kits contain protective wipes that may be contaminated with Bacillus cereus. |
| Root cause | Nonconforming Material/Component |
| Action | Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210. |
| Quantity | 520 kits |
| Distribution | UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960248 | GENERAL PROCEDURE KIT Physician Industries, Inc., Apr 12, 1996 |