Warm Air Model 135 Warming Units.
FDA device recall Z-0374-05 · posted 2004-12-30 · Terminated
Recall details
- Recalling firm
- Cincinnati Sub-Zero Products
- Reason for recall
- Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device.
- Action taken
- The firm notified consignees by certified letter on November 5, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTE
- Quantity affected
- 649 units.
- Distribution
- The product was distributed throughout the United States and to foreign countries including Saudi Arabia, Taiwan, Japan, and Canada.
- Date initiated
- 2004-11-05
- Date posted
- 2004-12-30
- Date terminated
- 2008-10-29
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WARM AIR WARMING UNIT (K942599) | Cincinnati Sub-Zero Products, Inc. | 1995-01-24 |