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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Comed PICC Insertion Tray		see related information
Date Posted August 14, 2008
Recall Number Z-1635-2008
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
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.
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
 
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