BEUDAMED
    FDA Recall Terminated

    Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton

    Recall: Z-1235-2007 · Initiated July 30, 2007

    Recall

    Recall Number
    Z-1235-2007
    Event Number
    39386
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 30, 2007
    Posted
    September 20, 2007
    Terminated
    April 1, 2008
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton

    Reason

    Particulate matter in product.

    Action

    The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.

    Distribution

    The products were shipped to distributors nationwide.

    Quantity

    33,240 units