Drug recall
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath…
FDA recall event 73376 · Class II · Argon Medical Devices, Inc
Key facts
| Event ID | 73376 |
|---|---|
| Recall numbers | Z-1029-2016 |
| Recalling firm | Argon Medical Devices, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths. |
| Initiation date | Feb 17, 2016 |
| Report date | Mar 9, 2016 |
| Termination date | Mar 8, 2017 |
| City | Athens |
| State | TX |
| Country | United States |
| FEI number | 1625425 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: