Class II — Vascutek, Ltd.
| Recalling firm | VASCUTEK LTD. |
|---|---|
| Registered facility | VASCUTEK LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
| Product | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t |
| Quantity | 159 total vascular grafts and patches |
| Distribution | Distribution was made to PR and Guam. |
| Initiated | 2021-07-08 |
| Classified | 2021-09-24 |
| Terminated | 2024-08-19 |
| Recall number | Z-2543-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vascutek, Ltd. (Z-2543-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88278/
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