Cincinnati Sub-Zero Products Inc: Medical Device Recall in 2014 - (Recall #: Z-1679-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 8, 2014

Date Posted: June 11, 2014

Recall Number: Z-1679-2014

Event ID: 68356

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

Status: Terminated

Product Quantity: 7 units

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated