BEUDAMED
    FDA Recall Terminated

    PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

    Recall: Z-2048-2015 · Initiated May 27, 2015

    Recall

    Recall Number
    Z-2048-2015
    Event Number
    71420
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    May 27, 2015
    Posted
    July 8, 2015
    Terminated
    February 10, 2016
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

    Reason

    Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

    Action

    BARD sent an Urgent Notification letter dated May 27, 2015, to all affected consignees via FedEx. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed that they may choose to return the affected product to Bard Access Systems or use with the understanding that the correct expiration date is November 2015 (2015-11). Customers with questions were instructed to call 1-800-290-1689. For questions regarding this recall call 801-522-5974.

    Distribution

    Nationwide Distribution