BEUDAMED
    FDA Recall Terminated

    Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit

    Recall: Z-0939-2012 · Initiated October 17, 2011

    Recall

    Recall Number
    Z-0939-2012
    Event Number
    60016
    Firm
    Vital Signs Devices, a GE Healthcare Company
    FEI Number
    2242551
    Product Code
    OGL
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    October 17, 2011
    Posted
    February 2, 2012
    Terminated
    January 15, 2013
    Address
    20 Campus Rd, Totowa, NJ, 07512-1210

    Description

    Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit

    Reason

    Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.

    Action

    GE Healthcare sent a recall letter/return response form dated October 17, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to not use the affected product, isolate and discard all affected product. Fill out the attached Confirmation form and fax back to 800-535-7923 per the instructions to obtain replacement Busse IV Start Kits. Also, consignees were instructed to return the attached response form even if no recalled product was in their inventory. If they forwarded any affected product to any other healthcare institutions, they should forward a copy of the letter to those institutions. For any questions regarding this recall call 1-800-932-0760.

    Distribution

    Nationwide and Foreign

    Quantity

    6675 kits