Device recall
Z-1846-2020: Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI…
FDA device recall · Class I · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-1846-2020 |
|---|---|
| Recall event | 85057 |
| Product | Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483 |
| Product code | DXE |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 1, 2023 |
| 510(k) numbers | K970762 |
| FEI number | 2027111 |
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