BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes, NJ 07417

    Recall: Z-0253-2007 · Initiated September 8, 2006

    Recall

    Recall Number
    Z-0253-2007
    Event Number
    36585
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 8, 2006
    Posted
    December 6, 2006
    Terminated
    May 8, 2007
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes, NJ 07417

    Reason

    Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.

    Action

    Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed

    Distribution

    Worldwide, including USA, Canada, and Australia.

    Quantity

    1,744,400