Recall Z-0654-2017 ยท DWS Instruments, Surgical, Cardiovascular
Cincinnati Sub-Zero Products Inc
The Hemotherm 400CE 115v, containing power board p/n 39945
| Date | Nov 22, 2016 (initiated Nov 7, 2016) |
| Status | Terminated |
| Reason | The device may not maintain water flow or temperature control. |
| Root cause | Material/Component Contamination |
| Action | Cincinnati Sub-Zero sent an Urgent Medical Device Correction letter date November 7, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm has notified all customers to discontinue use and contact CSZ. Upon receipt of the new board, immediately remove and discard the affected power board and replace it with the newly provided power board. The complete and return the customer response form. For further questions, please call (513) 772-8810 |
| Quantity | 50 |
| Distribution | US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC. |
| 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 |