Medical device recalls Moderate risk

Cincinnati Sub-Zero Products Inc recalls Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local…

Recall date
January 7, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1129-2015
FDA classification
Class II
Brand / firm
Cincinnati Sub-Zero Products Inc
Sold / distributed
Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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