Recall Z-1129-2015 ยท ILO Pack, Hot Or Cold, Water Circulating
Cincinnati Sub-Zero Products Inc
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.
| Date | Feb 19, 2015 (initiated Jan 7, 2015) |
| Status | Terminated |
| Reason | Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. |
| Root cause | Process design |
| Action | 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 |
| Quantity | 1390 |
| 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. |
| FDA record | Open on fda.gov |