Recall Z-0161-2011 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; Contains sterile and non-pyrogenic if package is unopened and undamaged. Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536
| Date | Oct 28, 2010 (initiated Sep 15, 2010) |
| Status | Terminated |
| Reason | Incorrect expiration date - The outer boxes of the IP2P Licox Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring Probes, Lot 250210A are labeled with an incorrect shelf life date (10 months too long). |
| Root cause | Employee error |
| Action | Integra issued Urgent Product Recall Notification letters dated September 16, 2010 to US customers and foreign consignees, identifying the affected lots and actions to be taken by customers. Affected product is not to be further distributed and should be quarantined pending return to the firm. Customers and Distribors should contact Integra Customer Service for a Returned Material Authorization Number, and then return the product to the Distribution Center. In addition, a Recall Acknowledgement and Return Form is to be completed and returned. Customers can contact Integra at 609 936-2495. |
| Quantity | 23kits |
| Distribution | Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040235 | LICOX PMO BRAIN MONITORING SYSTEM Integra LifeSciences Corporation, Apr 20, 2004 |