Z-0035-2010

WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and...

Name: Z-0035-2010 WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and...
Creator: Cincinnati Sub-Zero Products Inc
Published: 2009-02-16
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2009-02-16 / Terminated / root cause: manufacturing process

FDA source

Cincinnati Sub-Zero Products Inc began a recall of WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for... on 2009-02-16. The reason FDA records is "The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit". 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-0035-2010
Status: Terminated
Initiated: 2009-02-16
Posted: 2009-10-29
Terminated: 2012-09-19
Recalling firm: Gentherm Medical, LLC
Product: WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Product code: DWJ System, Thermal Regulating
Reason for recall: The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent an "URGENT Medical Device Recall' notice via First Class Mail on 2/16/2009 (Note: the letter is dated 2/13/2009). The notice informs the customers of the potential for the device to overheat and of the 'small number of customer complaints received by CSZ concerning this issue. In addition, the notice asks that the customers inspect their units for signs of discoloration indicative of a faulty connector. In the notice, the customers were instructed to return the product to CSZ for repair by contacting their Customer Service division and obtaining a Return Authorization number and specific instructions concerning packaging and returning of the unit(s) for repair. The customer is also instructed to complete the attached Recall Response Form which accompanies the recall notification. The notification provides that customer with a toll-free number at (800) 989-7373ext.3234 or call collect at (513) 719-3234 to reach CSZ representative between the hours of 8:30 a.m. until 4:30 P.M. Monday through Friday EST. Once the customer ships the recalled unit to CSZ, the firm will repair the unit(s) using new connectors manufactured, after which time, the repaired unit is returned to distribution for customer use.
Quantity in commerce: 2,674 units
Distribution: Nationwide Distribution -- DE, TX, PA, NJ, LA, MI, GA, MA, OH, KY, NY, FL, NV, NC, MT, RI, WA, MN, AL, CT, MD, TN, UT, VA, CO, MO, IA, AZ, AR, IN, NE, KS, WI, ME, MS, and Puerto Rico.
Product codes and lots: Serial Numbers 994-1350001 to 083-1355822..

Product code DWJ

K942599Class IIWarm Air Warming UnitCincinnati Sub-Zero Products, Inc. / cleared 1995-01-24

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)