Device recall
Z-0761-2019: Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code…
FDA device recall · Class II · Stihler Electronic Gmbh
Key facts
| Recall number (Z-number) | Z-0761-2019 |
|---|---|
| Recall event | 81755 |
| Product | Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow. |
| Product code | KOC |
| Recalling firm | Stihler Electronic Gmbh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2020 |
| 510(k) numbers | K082758 |
| FEI number | 3001733054 |
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