Device recall
Z-1139-2019: A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad…
FDA device recall · Class II · Pintler Medical LLC
Key facts
| Recall number (Z-number) | Z-1139-2019 |
|---|---|
| Recall event | 82531 |
| Product | A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol |
| Product code | DWJ |
| Recalling firm | Pintler Medical LLC |
| Recall class | Class II |
| Status | Completed |
| 510(k) numbers | K113705 |
| FEI number | 3009976772 |
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