FEI 3002808437

Vascutek Ltd.

Newmains Avenue, Inchinnan Renfrewshire, GB

MDR events574All time

Recalls6All time

Registered products7

Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)

Registered product codes

7 product codes

Recent MDR events

574 on file

Recalls

6 on file

Open, ClassifiedMar 4, 2026
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
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TerminatedJun 26, 2015
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
View FDA record ↗
TerminatedJun 26, 2015
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
View FDA record ↗
TerminatedAug 18, 2014
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).
View FDA record ↗
TerminatedUnknown
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
View FDA record ↗
TerminatedUnknown
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
View FDA record ↗

Compliance history

Matched by FEI 3002808437.

FDA inspections

0 on file

No inspections on file for this FEI number.

Inspection citations

0 on file

No citations on file for this FEI number.

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.