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