FDA Recall
Terminated
The Hemotherm 400CE 115v, containing power board p/n 39945
Recall: Z-0654-2017
·
Initiated November 7, 2016
Recall
- Recall Number
- Z-0654-2017
- Event Number
- 75641
- Firm
- Cincinnati Sub-Zero Products Inc
- FEI Number
- 1516825
- Product Code
- DWS
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- November 7, 2016
- Posted
- November 22, 2016
- Terminated
- February 22, 2017
- Address
- 12011 Mosteller Rd, Cincinnati, OH, 45241-1528
Description
The Hemotherm 400CE 115v, containing power board p/n 39945
Reason
The device may not maintain water flow or temperature control.
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
Distribution
US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
Quantity
50