Recall Z-1825-2017 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Cincinnati Sub-Zero Products Inc
Hemotherm CE, model 400CE, Heater-Cooling Device
| Date | Mar 9, 2017 |
| Status | Terminated |
| Reason | Improperly rated fuses were used in the manufacture of the device. |
| Root cause | Component design/selection |
| Action | Letters were sent to customers and distributors instructing them to immediately cease use and/or further distribution of affected product, remove and discard the affected fuses and replace with the new fuses provided by CSZ, and complete and return the Field Action Response Form. |
| Quantity | 390 devices |
| Distribution | Worldwide distribution. The recalled product was distributed to the following states: AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, and WI. The recalled product was distributed to the following countries: Mexico, Taiwan. There are no Canada accoun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM Cincinnati Sub-Zero Products, Inc., Dec 18, 2012 |