BEUDAMED
    FDA Recall Terminated

    Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.

    Recall: Z-1962-2020 · Initiated November 18, 2019

    Recall

    Recall Number
    Z-1962-2020
    Event Number
    85379
    Firm
    W. L. Gore & Associates Inc.
    FEI Number
    3007284313
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 18, 2019
    Terminated
    May 13, 2020
    Address
    32360 N North Valley Pkwy, Phoenix, AZ, 85085-4228

    Description

    Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.

    Reason

    The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.

    Action

    The recalling firm issued Field Safety Notices dated 11/19/2019 with FSN Ref and FSCA Ref numbers of #0000000-11152019-001-R titled "Mislabelled 16Fr Introducer Sheaths Labelled as 14FR (3 lots)" issued via email and overnight mail. Return of the devices was requested.

    Distribution

    All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.

    Quantity

    141 devices