Recall Z-0782-2010 ยท ILO Pack, Hot Or Cold, Water Circulating
Cincinnati Sub-Zero Products Inc
TempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
| Date | Feb 4, 2010 (initiated Nov 14, 2009) |
| Status | Terminated |
| Reason | Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured. |
| Root cause | Other |
| Action | On November 14, 2009, Cincinnati Sub-zero Products, Inc. (CSZ) sent a recall notification letter and response letter to customers. A second notice dated December 10, 2009 was also issued to customers. Customers were instructed in the notifications to assume the recalled product is not sterile and do not use. CSZ requested all affected product be returned to their firm for replacement. Customers are to complete and return the response letter acknowledging receipt of the recall letter. Direct questions to CSZ by calling Customer Service at 1-800- 989-7373. Customers may also call 1-800-989 |
| Quantity | 8,872 cartons of ten + 677 each (89,397 total) |
| Distribution | Worldwide Distribution -- United States (AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI & WV), Canada, France, Germany, Ireland, Israel, New Zealand, Singapore, and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.