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.
- Company
- Cincinnati Sub-Zero Products Inc
- Recall Initiated
- January 7, 2015
- Posted
- February 19, 2015
- Terminated
- June 19, 2015
- Recall Number
- Z-1129-2015
- Quantity
- 1390
- Firm Location
- Cincinnati, OH
Reason for Recall
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
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.
Lot / Code Info
Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.
Root Cause
Process design
Action Taken
Cincinnati Sub-Zero sent an Urgent Medical Device Recall Field Action Notice dated January 7, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use and/or further distribution of the affected product. Customers were instructed to obtain a Return Material Authorization Number and return the pad(s) for exchange. Customers with questions were instructed to call 1-800-989-7373 or 513-772-8810. Customers were also asked to commplete and return the enclosed Response Form as soon as possible by fax to (513)772-9119 to acknowledge receipt of the notification and to inform CSZ that they have performed the requested actions. For questions regarding this recall call 513-772-8810, ext 6816