BEUDAMED
    FDA Recall Terminated

    18G Catheter is a component in various kits.

    Recall: Z-1133-04 · Initiated April 16, 2004

    Recall

    Recall Number
    Z-1133-04
    Event Number
    28911
    Firm
    Braun, B Medical Inc
    FEI Number
    2523676
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 16, 2004
    Posted
    July 22, 2004
    Terminated
    September 14, 2004
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    18G Catheter is a component in various kits.

    Reason

    Catheter separated from the hub.

    Action

    The recalling firm issued a recall notification letter on March 19, 2004 to their direct accounts. The letter identified the problem and instructs the direct account to destroy individual units but return unopened cases to the recalling firm.

    Distribution

    The units were sent to medical facilities in the following states, as listed: CA, CO, DC, FL, GA, IL, LA, MA, MI, MD, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WI, WV The product was also distributed to the following foreign accounts located in Germany, Japan, Puerto Rico, and South America.

    Quantity

    1176 units