BEUDAMED
    FDA Recall Terminated

    Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxygen masks and blood pressure cuffs use on pediatric patients

    Recall: Z-2704-2011 · Initiated April 26, 2011

    Recall

    Recall Number
    Z-2704-2011
    Event Number
    58857
    Firm
    Vital Signs Devices, a GE Healthcare Company
    FEI Number
    2242551
    Product Code
    BYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2011
    Posted
    June 29, 2011
    Terminated
    January 14, 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 kit contains oxygen masks and blood pressure cuffs use on pediatric patients

    Reason

    Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask.

    Action

    GE issued an URGENT MEDICAL DEVICE CORRECTION letter dated April 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the affected product, isolate all affected product, complete the attached confirmation form and fax back per the instructions and return any unused product. For any product forwarded to any other healthcare institution, customers were instructed to forward a copy of the URGENT MEDICAL DEVICE CORRECTION letter to those institutions. For any questions contact Vital Signs Customer Service at 1-800-932-0760.

    Distribution

    IL

    Quantity

    33,002 units