Device recall
Z-1029-2016: ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and…
FDA device recall · Class II · Argon Medical Devices, Inc
Key facts
| Recall number (Z-number) | Z-1029-2016 |
|---|---|
| Recall event | 73376 |
| Product | ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. |
| Product code | DRE |
| Recalling firm | Argon Medical Devices, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2017 |
| 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