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 cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively). |
| Product | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company |
| Quantity | 63,162 |
| Distribution | Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV. |
| Initiated | 2014-07-15 |
| Classified | 2014-08-18 |
| Terminated | 2015-03-19 |
| Recall number | Z-2266-2014 |
| 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-2266-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68952/
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