Class II — Vascutek, Ltd.
| Recalling firm | VASCUTEK LTD. |
|---|---|
| Registered facility | VASCUTEK LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. |
| Product | Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. |
| Quantity | 12 |
| Distribution | Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany. |
| Initiated | 2015-05-15 |
| Classified | 2015-06-26 |
| Terminated | 2015-10-20 |
| Recall number | Z-1913-2015 |
| 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-1913-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71305/
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