BEUDAMED
    FDA Enforcement Class II Terminated

    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.

    Recall: Z-2120-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2120-2017
    Event ID
    77132
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    April 25, 2017
    Classification Date
    May 19, 2017
    Termination Date
    August 21, 2017
    Address
    605 N 5600 W, Salt Lake City, UT, 84116-3738, United States

    Description

    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.

    Reason

    StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.

    Code Info

    Lot Number JUAQF675, Exp 2/28/2019

    Distribution

    Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.

    Quantity

    4,500 units