Device recall
Z-0801-2019: Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0801-2019 |
|---|---|
| Recall event | 81490 |
| Product | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845. |
| Product code | CHL |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 2, 2024 |
| 510(k) numbers | K051968 |
| FEI number | 3010420736 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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