Recall Z-0035-2010 ยท DWJ System, Thermal Regulating
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.
| Date | Oct 29, 2009 (initiated Feb 16, 2009) |
| Status | Terminated |
| 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 an |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942599 | WARM AIR WARMING UNIT Cincinnati Sub-Zero Products, Inc., Jan 24, 1995 |