BEUDAMED
    FDA Enforcement Class II Terminated

    Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

    Recall: Z-1129-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1129-2015
    Event ID
    70207
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cincinnati Sub-Zero Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2015
    Initiation Date
    January 7, 2015
    Classification Date
    February 19, 2015
    Termination Date
    June 19, 2015
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241-1528, United States

    Description

    Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

    Reason

    Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

    Code Info

    Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.

    Distribution

    Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.

    Quantity

    1390