Home / Recalls / Cincinnati Sub-Zero Products Inc / Z-1679-2014

Z-1679-2014 Class II Terminated

Recalled by Cincinnati Sub-Zero Products Inc — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
June 11, 2014
Initiation Date
January 8, 2014
Termination Date
June 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 units

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

Distribution Pattern

The product was distributed to one customer in MI, and internationally (Taiwan)

Code Information

Model Number 222S; Serial #s: 133-2-00697, 133-2-00698; 133-2-00699; 133-2-00700; 133-2-00701; 133-2-00702; and 133-2-00703:.Part # 86165

Other recalls by Cincinnati Sub-Zero Products Inc

  • Z-0629-2018 Class II — Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product U (November 27, 2017)
  • Z-1825-2017 Class II — Hemotherm CE, model 400CE, Heater-Cooling Device (March 9, 2017)
  • Z-0654-2017 Class II — The Hemotherm 400CE 115v, containing power board p/n 39945 (November 7, 2016)
  • Z-1129-2015 Class II — Cold Therapy Pad - cold water circulating pad, one unit per package. The pads (January 7, 2015)
  • Z-2209-2013 Class II — Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Most (September 3, 2013)
  • Z-0443-2014 Class II — Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Expo (May 15, 2013)