The Hemotherm 400CE 115v, containing power board p/n 39945
- Company
- Cincinnati Sub-Zero Products Inc
- Recall Initiated
- November 7, 2016
- Posted
- November 22, 2016
- Terminated
- February 22, 2017
- Recall Number
- Z-0654-2017
- Quantity
- 50
- Firm Location
- Cincinnati, OH
Reason for Recall
The device may not maintain water flow or temperature control.
Distribution
US Distribution to the states of : CA, FL, GA, MA, MN, NC, NJ, OH, PA and SC.
Lot / Code Info
154-10360CE 163-10502CE 163-10512CE 163-10527CE 164-10537CE 163-10491CE 163-10503CE 163-10513CE 163-10528CE 164-10538CE 163-10493CE 163-10504CE 163-10514CE 163-10529CE 164-10539CE 163-10495CE 163-10505CE 163-10515CE 163-10530CE 164-10540CE 163-10496CE 163-10506CE 163-10521CE 164-10531CE 164-10543CE 163-10497CE 163-10507CE 163-10522CE 164-10532CE 164-10544CE 163-10498CE 163-10508CE 163-10523CE 164-10533CE 164-10545CE 163-10499CE 163-10509CE 163-10524CE 164-10534CE 164-10547CE 163-10500CE 163-10510CE 163-10525CE 164-10535CE 164-10548CE 163-10501CE 163-10511CE 163-10526CE 164-10536CE 164-10549CE
Root Cause
Material/Component Contamination
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