BEUDAMED
    FDA Recall Terminated

    Gertie Marx PainPak, Lot number 0504305, Reorder number 4060

    Recall: Z-1113-04 · Initiated June 18, 2004

    Recall

    Recall Number
    Z-1113-04
    Event Number
    29389
    Firm
    Spinal Specialties, Inc
    FEI Number
    1000306134
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2004
    Posted
    July 20, 2004
    Terminated
    October 20, 2004
    Address
    12001 Network Blvd, Bldg F # 208, San Antonio, TX, 78249-3351

    Description

    Gertie Marx PainPak, Lot number 0504305, Reorder number 4060

    Reason

    Kit contains lidocaine, which has particulate matter in its ampule.

    Action

    Firm notified consignees who received the product by telephone on 6/18/2004, then sent a letter via facsimile and next day air delivery.

    Distribution

    El Paso, Texas and Lansing, Michigan

    Quantity

    60 units