Device recall
Z-1529-2021: LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock…
FDA device recall · Class II · LeMaitre Vascular, Inc.
Key facts
| Recall number (Z-number) | Z-1529-2021 |
|---|---|
| Recall event | 87689 |
| Product | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00. |
| Product code | DXT |
| Recalling firm | LeMaitre Vascular, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 29, 2022 |
| 510(k) numbers | K973334 |
| FEI number | 1220948 |
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