Device recall
Z-0035-2010: WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V…
FDA device recall · Class II · Cincinnati Sub-Zero Products Inc
Key facts
| Recall number (Z-number) | Z-0035-2010 |
|---|---|
| Recall event | 51228 |
| 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. |
| Product code | DWJ |
| Recalling firm | Cincinnati Sub-Zero Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 19, 2012 |
| 510(k) numbers | K942599 |
| FEI number | 1516825 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database