BEUDAMED
    FDA Recall Terminated

    22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

    Recall: Z-0886-05 · Initiated April 15, 2005

    Recall

    Recall Number
    Z-0886-05
    Event Number
    31950
    Firm
    Spinal Specialties, Inc
    FEI Number
    1000306134
    Product Code
    CAZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 15, 2005
    Posted
    June 14, 2005
    Terminated
    November 2, 2005
    Address
    12001 Network Blvd, Bldg F # 208, San Antonio, TX, 78249-3351

    Description

    22G Nerve Block PainPak, Reorder No.:3269, kit manufactured by Integra Spinal Specialties, San Antonio, Texas.

    Reason

    Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.

    Action

    The firm initiated the recall via letter on April 15, 2005.

    Distribution

    VA, OH, TX, CA, IL, and FL

    Quantity

    542 kits