BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

    Recall: Z-1923-2013 · Initiated May 1, 2013

    Recall

    Recall Number
    Z-1923-2013
    Event Number
    65322
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 1, 2013
    Posted
    August 7, 2013
    Terminated
    December 4, 2015
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.

    Reason

    BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

    Action

    BD sent a Product Advisory Notice dated May 3, 2013, via UPS to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard filled tubes since it is possible they will contain less blood volume (low draws), replace the Luer Adaptor unit being used with a fresh unit, and continue to draw blood samples using the fresh unit. Customers with questions were instructed to contact BD Technical Service at 1-800-631-0174, Option 4, or contact them through website: www.bd.com/vacutainer/contact. For questions regarding this recall call 201-847-6800.

    Distribution

    Nationwide Distribution

    Quantity

    37,906,400 units