Z-1679-2014Class II

115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature...

Name: Z-1679-2014 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2014-01-08
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2014-01-08 / Terminated / root cause: manufacturing process

FDA source

Cincinnati Sub-Zero Products Inc began a recall of 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... on 2014-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1679-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-06-10
Terminated: 2014-06-06
Recalling firm: Gentherm Medical, LLC
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.
Product code: DWJ System, Thermal Regulating
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
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: The firm initiated a telephone notification on 01/08/2014, followed by a written notification which was sent to the customers via letter or email on 01/31/2014. URGENT Medical Device Field Action (January 31, 2014) REF: 115V Blanketrol II Model 22S Hyper-Hypothermia System (1) Discontinue Use and contact CSZ (2)Upon receipt of new 115V (p/n 91113) solenoid coil(s), immediately remove and destroy/discard all the affected 220V (p/n 3600) solenoid coil(s) (3)After the affected 220V (p/n 36007) solenoid coil(s) have been removed, discard and replaced, please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to imform CSZ that you have performed and completed the requested actions. Return the form by fax
Quantity in commerce: 7 units
Distribution: The product was distributed to one customer in MI, and internationally (Taiwan)
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1679-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1679-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code DWJ

K110104Class IIBlanketrol II Hyper-Hypothermia Temperature Managment SystemCincinnati Sub-Zero Products, Inc. / cleared 2011-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)