FDA-Device2015-02-25Class II

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.

Cincinnati Sub-Zero Products Inc
Hazard

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

Sold states
Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.
Affected count
1390
Manufactured in
12011 Mosteller Rd, Cincinnati, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1129-2015

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