Device recall
Z-2806-2020: ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm…
FDA device recall · Class II · Argon Medical Devices, Inc
Key facts
| Recall number (Z-number) | Z-2806-2020 |
|---|---|
| Recall event | 86036 |
| Product | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various… |
| Product code | DRE |
| Recalling firm | Argon Medical Devices, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2023 |
| 510(k) numbers | K780126 |
| FEI number | 1625425 |
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