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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Licox

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  Class 2 Device Recall Integra Licox see related information
Date Initiated by Firm February 18, 2010
Date Posted April 20, 2010
Recall Status1 Terminated 3 on April 20, 2010
Recall Number Z-1422-2010
Recall Event ID 54769
510(K)Number K040235  
Product Classification brain oxygen probe - Product Code GWM
Product Integra, Licox Ref 1P2.P;
Brain PMO-Probe Kit
Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes,
REF CC1/P1 Combined Oxygen & Temperature Probe.
Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
Code Information Catalog number CC1P1, Serial number SN 776; Lot number 160110A
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Lauren Moose
609-936-6876
Manufacturer Reason
for Recall		 One probe that had failed a product release test was inadvertently packaged and released into inventory in Integra's distribution center.
FDA Determined
Cause 2		 Process control
Action An Integra NeuroSpecialist was sent to retrieve the probe on February 18, 2010, followed by a formal letter.
Quantity in Commerce 1
Distribution One hospital in Omaha, NE.
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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