Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2266-2014 — Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

U.S. FDA — Device Enforcement · United Kingdom · 2014-07-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2266-2014
Date of alert
2014-07-15
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Vascutek, Ltd.
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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