Drug recall
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid…
FDA recall event 88278 · Class II · Vascutek, Ltd.
Key facts
| Event ID | 88278 |
|---|---|
| Recall numbers | Z-2542-2021, Z-2543-2021 |
| Recalling firm | Vascutek, Ltd. |
| Product type | Devices |
| Products | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t, The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
| Initiation date | Jul 8, 2021 |
| Report date | Oct 6, 2021 |
| Termination date | Aug 19, 2024 |
| City | Inchinnan |
| Country | United Kingdom |
| FEI number | 3002808437 |
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: