Device recall
Z-1077-2021: Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N…
FDA device recall · Class II · Argon Medical Devices, Inc
Key facts
| Recall number (Z-number) | Z-1077-2021 |
|---|---|
| Recall event | 87000 |
| Product | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO, |
| Product code | DYB |
| Recalling firm | Argon Medical Devices, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2023 |
| 510(k) numbers | K022634 |
| FEI number | 1625425 |
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