Recall Z-1679-2014— Cincinnati Sub-Zero Products Inc
Class II · Terminated
Class II FDA medical device recall by Cincinnati Sub-Zero Products Inc, initiated 2014-01-08, terminated 2014-06-06. It names one FDA 510(k) clearance: K110104. Product: 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.. Reason: The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but.
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-08
- Terminated
- 2014-06-06
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
Reason for recall
The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but
Data sourced from openFDA. This site is unofficial and independent of the FDA.