—#94583

Product

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

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K040235
Affected 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.

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.

Timeline

Recall initiated: 2010-09-15
Posted by FDA: 2010-10-28
Terminated: 2012-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.