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U.S. Department of Health and Human Services

Class 1 Device Recall Integra PICC INSERTION TRAY

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  Class 1 Device Recall Integra PICC INSERTION TRAY see related information
Date Initiated by Firm May 19, 2011
Date Posted June 22, 2011
Recall Status1 Terminated 3 on August 01, 2011
Recall Number Z-2575-2011
Recall Event ID 58995
510(K)Number K960248  
Product Classification PICC INSERTION TRAY - Product Code FMF
Product Integra Pain Management Disposable, Convenience Kit
PICC INSERTION TRAY, Reorder Number 3403203, Sterile/EO, Integra LifeSciences Corporation, West Valley City, Utah 84119.
Code Information Lot/Serial Number(s): W1009188, W1009261, W1011070, W1101120, W1102014, W1103011
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-936-6824
Manufacturer Reason
for Recall		 Kits contain protective wipes that may be contaminated with Bacillus cereus.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Integra LifeSciences consignees were notified by Urgent Medical Device Recall letter on May 20, 2011 and told to quarantine any remaining product and to notify customers to return any remaining product to them. Further information is available at (800) 241-2210.
Quantity in Commerce 520 kits
Distribution UT
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 = FMF and Original Applicant = PHYSICIAN INDUSTRIES, INC.
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