BEUDAMED
    FDA Recall Terminated

    Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul

    Recall: Z-1439-04 · Initiated July 6, 2004

    Recall

    Recall Number
    Z-1439-04
    Event Number
    29938
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 6, 2004
    Posted
    September 9, 2004
    Terminated
    November 30, 2004
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul

    Reason

    drug ampuls in kits contain particulates

    Action

    The recalling firm/kit manufacturer issued a recall letter dated 7/8/04 to its customers informing them of the problem and to return the product.

    Distribution

    The products were shipped to 145 medical facilities and 79 distributors nationwide. The products were also shipped to 6 government accounts in FL, NC, NY, OH, and PA.

    Quantity

    2261 cases