Z-2888-2011

WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia...

Name: Z-2888-2011 WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2011-06-01
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2011-06-01 / Terminated / root cause: design

FDA source

Cincinnati Sub-Zero Products Inc began a recall of WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and... on 2011-06-01. The reason FDA records is "Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2888-2011
Status: Terminated
Initiated: 2011-06-01
Posted: 2011-07-27
Terminated: 2013-08-02
Recalling firm: Gentherm Medical, LLC
Product: WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket
Product code: DWJ System, Thermal Regulating
Reason for recall: Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket.
Root cause tag: design
FDA root cause: Device Design
Action: Cincinnati Sub-Zero Products, Inc. sent an 'URGENT Medical Device Recall Field Action Notice" dated July 12, 2011 to all affected customers. The letter includes: description of product, problem, and information to request a repair tubing kit free of charge. It also asks customers to complete and return a "Recall Response Form". For additional information e-mail [email protected] or call (800) 989-7373 or (513) 772-8810.
Quantity in commerce: 5474 units
Distribution: Worldwide Distribution: (USA) Nationwide, and the countries of Australia, Brazil, Bulgaria, Canada, Chile, Ecuador, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, The Netherlands, Turkey, U.A.E., UK, Uruguay, Venezuela, and Vietnam.
Product codes and lots: 100V - Part Number: 86185; 115V - Part Number: 86186; and 230V - Part Number 86187. Serial Numbers: 032-1351178 thru 104-1356908 and 104-1356910 to 104-1356915.

Product code DWJ

K101148Class IIWarm Air Model 135 Hyperthermia System and BlanketsCincinnati Sub-Zero Products, Inc. / cleared 2010-10-01

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)