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U.S. Department of Health and Human Services

Class 2 Device Recall Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;

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  Class 2 Device Recall Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P; see related information
Date Initiated by Firm September 15, 2010
Date Posted October 28, 2010
Recall Status1 Terminated 3 on April 18, 2012
Recall Number Z-0161-2011
Recall Event ID 56820
510(K)Number K040235  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
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
Code Information 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.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Lauren Moose
609-216-2978
Manufacturer 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).
FDA Determined
Cause 2		 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 in Commerce 23kits
Distribution Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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