Recall Z-2888-2011 ยท DWJ System, Thermal Regulating
Cincinnati Sub-Zero Products Inc
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
| Date | Jul 27, 2011 (initiated Jun 1, 2011) |
| Status | Terminated |
| Reason | 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 | 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 WA135-2011@cszinc.com or call (800) 989-7373 or (513) 772-8810. |
| Quantity | 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 Arab |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS Cincinnati Sub-Zero Products, Inc., Oct 1, 2010 |