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U.S. Department of Health and Human Services

Class 2 Device Recall Comed PICC Insertion Tray

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 Class 2 Recall
Comed PICC Insertion Tray
see related information
Date Posted August 14, 2008
Recall Status1 Terminated on November 05, 2008
Recall Number Z-1635-2008
Recall Event ID 47373
Premarket Notification
510(K) Number
K960248 
Product Classification Syringe, Piston - Product Code FMF
Product Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791
Code Information Lot Numbers: W0801021, W801104, W0711154.
Recalling Firm/
Manufacturer
Integra Pain Management
3395 W 1820 S
Salt Lake City, Utah 84104-4921
Manufacturer Reason
for Recall
Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition.
Quantity in Commerce 500 kits
Distribution CO
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = PHYSICIAN INDUSTRIES, INC.
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