BEUDAMED
    FDA Recall Terminated

    Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351

    Recall: Z-0693-2020 · Initiated November 14, 2019

    Recall

    Recall Number
    Z-0693-2020
    Event Number
    84410
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DTM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 14, 2019
    Terminated
    October 5, 2020
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351

    Reason

    Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.

    Action

    Beginning 14-Nov-2019, Medtronic initiated an immediate Urgent Medical Device Recall via verbal communication to one (1) customer that was shipped the affected product according to Medtronic records. The customer was asked to identify and quarantine any unused affected product. The immediate communication was followed by a written urgent medical device recall notification beginning on 26-Nov-2019 to communicate the issue to the one (1) customer that received affected product. The consignee was asked to confirm receipt of urgent medical device recall notification via a Customer Confirmation Certificate. Medtronic is seeking the return of the affected product.

    Distribution

    CA

    Quantity

    24 units