BEUDAMED
    FDA Recall Terminated

    NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.

    Recall: Z-0125-2018 · Initiated October 6, 2017

    Recall

    Recall Number
    Z-0125-2018
    Event Number
    78391
    Firm
    Halyard Health, Inc
    FEI Number
    3011270181
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 6, 2017
    Posted
    November 18, 2017
    Terminated
    September 1, 2020
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 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.

    Action

    Customers were notified via FedEx on 10/06/2017. Instructions included to evaluate and quarantine any affected product in current inventory. For their direct distributors, instructions were to complete and return the response form and also coordinate the return of any affected product. If further distributed, those end users and customers were instructed to destroy any affected product.

    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