BEUDAMED
    FDA Enforcement Class II Terminated

    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.

    Recall: Z-3071-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3071-2017
    Event ID
    77555
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2017
    Initiation Date
    June 5, 2017
    Classification Date
    August 25, 2017
    Termination Date
    August 4, 2020
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.

    Reason

    The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.

    Code Info

    lot number 16X659

    Distribution

    Japan, China, US

    Quantity

    17280 units