Device recall
Z-0598-2018: 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket…
FDA device recall · Class II · 3M Company - Health Care Business
Key facts
| Recall number (Z-number) | Z-0598-2018 |
|---|---|
| Recall event | 79002 |
| Product | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist… |
| Product code | DWJ |
| Recalling firm | 3M Company - Health Care Business |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2020 |
| 510(k) numbers | K060865 |
| FEI number | 2110898 |
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