BEUDAMED
    FDA Enforcement Class III 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 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-2048-2015
    Event ID
    71420
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    May 27, 2015
    Classification Date
    July 8, 2015
    Termination Date
    February 10, 2016
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    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.

    Code Info

    Lot No: REYK1762, Item No. 1295108D

    Distribution

    Nationwide Distribution

    Quantity

    N/A