BEUDAMED
    FDA Recall Terminated

    Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)

    Recall: Z-2411-2008 · Initiated June 30, 2008

    Recall

    Recall Number
    Z-2411-2008
    Event Number
    49078
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 30, 2008
    Posted
    September 23, 2008
    Terminated
    May 5, 2009
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)

    Reason

    incorrect burette was packaged with the product

    Action

    The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.

    Distribution

    Nationwide.

    Quantity

    2340 units