BEUDAMED
    FDA Recall Open, Classified

    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

    Recall: Z-0939-2021 · Initiated December 28, 2020

    Recall

    Recall Number
    Z-0939-2021
    Event Number
    87013
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    MVR
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 28, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

    Reason

    Potential for the battery to lose its ability to be recharged.

    Action

    Written notification letter titled, "Urgent Medical Device Recall" was sent to all consignees on 12/28/2020 via first class mail. The letter instructs the consignee to locate all affected devices at their facility; contact Synovis MCA to arrange for product return for the firmware upgrade, power button update, and battery replacement, if applicable; complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to [email protected], even if the consignees does not have any inventory; and if the consignee distributes this product to other facilities or departments within their institution, to please forward a copy of this communication to them.

    Distribution

    Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD

    Quantity

    109 units