BEUDAMED
    FDA Recall Terminated

    ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients where clinically indicated; Monitoring of patient temperature

    Recall: Z-0456-2012 · Initiated October 21, 2011

    Recall

    Recall Number
    Z-0456-2012
    Event Number
    60636
    Firm
    Life Recovery Systems HD, LLC
    FEI Number
    3006059109
    Product Code
    NZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 21, 2011
    Posted
    January 11, 2012
    Terminated
    January 24, 2013
    Address
    150 Hopper Ave, Waldwick, NJ, 07463-1513

    Description

    ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients where clinically indicated; Monitoring of patient temperature

    Reason

    ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.

    Action

    Life Recovery Systems sent recall letters/return response forms dated 10/24/2011 to all consignees. Life Recovery Systems has expanded their recall to include additional units and to provide additional service to products out in the field. A new recall letter was sent to consignees on 4/27/2012.

    Distribution

    Nationwide Distribution including NY, NC, LA, NJ, AL. PA TX, KY, MO, MA, and TN

    Quantity

    28 units