BEUDAMED
    FDA Recall Terminated

    B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

    Recall: Z-2655-2014 · Initiated August 6, 2014

    Recall

    Recall Number
    Z-2655-2014
    Event Number
    69054
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    August 6, 2014
    Posted
    September 16, 2014
    Terminated
    January 29, 2015
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.

    Reason

    The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.

    Action

    B. Braun Medical Inc. provided the recall notification received from B. Braun Melsungen AG to Progressive Medical Inc. who is the initial importer of the product in the U.S. market. The notification was sent via FedEx and e-mail on/about August 6, 2014 and identified the product, problem, and action to be taken. The notification indicated that if the affected units were further distributed that any distributors are required to forward the letter on to their consignees.

    Distribution

    Distributed in the state of Missouri.

    Quantity

    8,640 units