The Hemotherm 400CE 115v, containing power board p/n 39945
FDA device recall Z-0654-2017 · posted 2016-11-22 · Terminated
Recall details
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- Reason for recall
- The device may not maintain water flow or temperature control.
- Action taken
- 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
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- DWS
- Quantity affected
- 50
- Distribution
- US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
- Date initiated
- 2016-11-07
- Date posted
- 2016-11-22
- Date terminated
- 2017-02-22
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |