BEUDAMED
    FDA Recall Terminated

    Pilling COOLEY SUMP-SUCTION TUBE, REF 351547

    Recall: Z-0846-2019 · Initiated January 7, 2019

    Recall

    Recall Number
    Z-0846-2019
    Event Number
    81918
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    JOL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 7, 2019
    Terminated
    November 4, 2021
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Pilling COOLEY SUMP-SUCTION TUBE, REF 351547

    Reason

    The internal tip is missing from the device, causing the device to not function as intended.

    Action

    The firm initiated the recall by letter on 01/07/2019. The firm requested the return of the units.

    Distribution

    TX, NY, DC and Philippines

    Quantity

    80 units