Recall Z-0781-2010 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
| 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 | 1,095 Blankets |
| 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
| K942599 | WARM AIR WARMING UNIT Cincinnati Sub-Zero Products, Inc., Jan 24, 1995 |