BEUDAMED
    FDA Enforcement Class II Terminated

    AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

    Recall: Z-0069-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0069-2018
    Event ID
    78366
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 15, 2017
    Initiation Date
    October 24, 2017
    Classification Date
    November 7, 2017
    Termination Date
    July 2, 2018
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

    Reason

    Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.

    Code Info

    Lot # 109138

    Distribution

    US Distribution to the state of : SC

    Quantity

    60 kits