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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 Device Recall Comed PICC Insertion Tray see related information
Date Initiated by Firm March 18, 2008
Date Posted August 14, 2008
Recall Status1 Terminated 3 on November 05, 2008
Recall Number Z-1635-2008
Recall Event ID 47373
510(K)Number K960248  
Product Classification PICC insertion tray - 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 UT 84104-4921
For Additional Information Contact
801-886-9505
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		 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 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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