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Recall Observatory FDA recall evidence

Device product

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.

Z-1129-2015

January 07, 2015

Class II

Product summary

Firm
Cincinnati Sub-Zero Products Inc
Event
Event 70207
Status
Terminated
Classification
Class II
Quantity
1390
Official record key
device-enforcement:Z-1129-2015

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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