WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduc
FDA device recall Z-2888-2011 · posted 2011-07-27 · Terminated
Recall details
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWJ
- Quantity affected
- 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, Mexic
- Date initiated
- 2011-06-01
- Date posted
- 2011-07-27
- Date terminated
- 2013-08-02
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS (K101148) | Cincinnati Sub-Zero Products, Inc. | 2010-10-01 |