Drug recall
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate…
FDA recall event 75213 · Class II · Argon Medical Devices, Inc
Key facts
| Event ID | 75213 |
|---|---|
| Recall numbers | Z-0051-2017 |
| Recalling firm | Argon Medical Devices, Inc |
| Product type | Devices |
| Products | MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath |
| Initiation date | Sep 8, 2016 |
| Report date | Oct 12, 2016 |
| Termination date | Jun 7, 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: