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
This recall has been terminated (originally issued October 28, 2010).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- September 15, 2010
- Posted
- October 28, 2010
- Terminated
- April 18, 2012
- Recall Number
- Z-0161-2011
- Quantity
- 23kits
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.
Lot / Code Info
Ref IP2P, Lot number: 250210A; Serial Numbers: 833, 834, 835, 836, 837, 838, 839, 841, 844, 846, 847, 848, 850, 851, 852, 853, 854, 855, 857, 858, 859, 860, 861, 862, 864.
Root Cause
Employee error
Action Taken
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.