BEUDAMED
    FDA Recall Terminated

    BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

    Recall: Z-1056-2013 · Initiated February 14, 2013

    Recall

    Recall Number
    Z-1056-2013
    Event Number
    64494
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 14, 2013
    Posted
    April 4, 2013
    Terminated
    August 6, 2013
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing.

    Reason

    The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags which are incorrectly labeled as Catalog #364953. BD advises any Customer who purchased this Kit that the Tube in this Kit is not a C&S tube. If a Customer relies solely on the polybag labeling and uses the Tube inside the Kit for the purpose of collecting urine for culture and sensitivity, it is possible

    Action

    BD Diagnostics sent a "Product Advisory Notice" dated February 14, 2013 via UPS Second Day Air to all end user customers. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. For questions regarding this recall call 201-847-5033.

    Distribution

    Nationwide Distribution including Arizona, California, Colorado, Georgia, Florida, Illinois, Iowa, Kentucky, Louisiana, Maryland, Massachussets, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington DC, Washington, West Virginia, and Wisconsin.

    Quantity

    236,400 units