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

Recall Z-0336-2014 — Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "Gelsoft Gelatin Impregnated Knitted Vascular ProsthesisSTRAIGHTSTERILEEOItem No: 631508Diameter 8mmUsable Length 15cmManufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire

U.S. FDA — Device Enforcement · United States · 2013-10-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0336-2014
Date of alert: 2013-10-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo Cardiovascular Systems Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0001765391

Reported risk: Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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