Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit
FDA device recall Z-0161-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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).
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GWM
- Quantity affected
- 23kits
- Distribution
- Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.
- Date initiated
- 2010-09-15
- Date posted
- 2010-10-28
- Date terminated
- 2012-04-18
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LICOX PMO BRAIN MONITORING SYSTEM (K040235) | Integra LifeSciences Corporation | 2004-04-20 |