Device recall
Z-1836-2020: ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
FDA device recall · Class II · Radiometer Medical ApS
Key facts
| Recall number (Z-number) | Z-1836-2020 |
|---|---|
| Recall event | 85166 |
| Product | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 |
| Product code | CHL |
| Recalling firm | Radiometer Medical ApS |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K041874 |
| FEI number | 3002807968 |
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