Z-0374-05

Warm Air Model 135 Warming Units

Name: Z-0374-05 Warm Air Model 135 Warming Units
Creator: Cincinnati Sub-Zero Products
Published: 2004-11-05
License: https://open.fda.gov/license/

Gentherm Medical, LLC / initiated 2004-11-05 / Terminated

FDA source

Cincinnati Sub-Zero Products began a recall of Warm Air Model 135 Warming Units on 2004-11-05. The reason FDA records is "Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0374-05
Status: Terminated
Initiated: 2004-11-05
Posted: 2004-12-30
Terminated: 2008-10-29
Recalling firm: Gentherm Medical, LLC
Product: Warm Air Model 135 Warming Units.
Product code: BTE
Reason for recall: Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.
FDA root cause: Other
Action: The firm notified consignees by certified letter on November 5, 2004.
Quantity in commerce: 649 units.
Distribution: The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.
Product codes and lots: All serial numbers.

Product code BTE

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