Class 2 Device Recall Comed PICC Insertion Tray

• Date Initiated by Firm: March 18, 2008
• Date Posted: August 14, 2008
• Recall Status: Terminated 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: 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