FDA Medical Device Recalls (openFDA)
Cincinnati Sub-Zero Products Inc: 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.
- Recall number
- Z-0035-2010
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-02-16
- Posted
- 2009-10-29
- Terminated
- 2012-09-19
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Serial Numbers 994-1350001 to 083-1355822..
- 510(k) numbers
- ["K942599"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 1516825
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28