BEUDAMED
    FDA Enforcement Class II Terminated

    Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.

    Recall: Z-0117-2018 · Reported November 29, 2017

    Enforcement

    Recall Number
    Z-0117-2018
    Event ID
    78391
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Halyard Health, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2017
    Initiation Date
    October 6, 2017
    Classification Date
    November 18, 2017
    Termination Date
    September 1, 2020
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.

    Reason

    Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

    Code Info

    Product Code 2216 with Lot AB6032U03; Product Code 22056 with Lot AB6032U12; Product Code 220569 with Lot AB6207U11

    Distribution

    Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV

    Quantity

    52,660 kits (2,633 cases) with 631,920 saline vials