BEUDAMED
    FDA Recall Open, Classified

    Fusion Bioline Vascular Graft, Part number M00201503046B0

    Recall: Z-1245-2023 · Initiated January 30, 2023

    Recall

    Recall Number
    Z-1245-2023
    Event Number
    91671
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    DSY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 30, 2023
    Posted
    March 10, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Fusion Bioline Vascular Graft, Part number M00201503046B0

    Reason

    One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm.

    Action

    On January 30, 2023, the firm notified customers via Urgent Medical Device Removal letters. Customers are asked to examine your inventory immediately for lot 25162546. Please note, the Lot number appears on the device shelf boxes only. If you have the affected lot, please stop using and remove the device from areas of use. You are entitled to a replacement at no cost to your facility. You will receive replacement upon your acknowledgement that you have product for return. Distributors who have shipped this product should notify their customers. Please contact Getinge Customer Service at 888-943-8872 between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product.

    Distribution

    US Nationwide distribution in the states of FL, IN, LA, MI, MO, NC, NV, NY, PA, TN, TX, VA, WA.

    Quantity

    1 (US)