FDAFDA · Food and drugs·Recall number Z-1679-2014
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.
Published June 11, 2014 · Recall initiated: January 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Distributor
- The product was distributed to one customer in MI, and internationally (Taiwan)
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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