BEUDAMED
    FDA Recall Terminated

    BD 25G Spinal Needles. (Spinal Anesthesia Needle)

    Recall: Z-0928-05 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-0928-05
    Event Number
    31657
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    June 25, 2005
    Terminated
    November 7, 2005
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD 25G Spinal Needles. (Spinal Anesthesia Needle)

    Reason

    A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface.

    Action

    The firm sent out notification letters on 3/16/2005.

    Distribution

    The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide.

    Quantity

    801580 units