Reported Aug 27, 2014 · Terminated

Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

Vascutek, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vascutek, Ltd. · Newmains Avenue · Inchinnan · N/A

Is this the product you have?

  • Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Lot codes and dates
  • 107 of 107 codes

    • 731030
    • 731032
    • 731034
    • 731036
    • 731038
    • 731206
    • 731218
    • 731220
    • 731222
    • 731224
    • 731226
    • 731228
    • 731407
    • 731506
    • 731507
    • 731508
    • 731509
    • 731510
    • 731512
    • 731514
    • 731516
    • 731608
    • 731809
    • 732010
    • 732030
    • 732032
    • 732034
    • 732038
    • 732211
    • 732412
    • 732518
    • 732520
    • 732522
    • 732524
    • 732526
    • 732528
    • 733006
    • 733007
    • 733008
    • 733010
    • 733012
    • 733014
    • 733016
    • 733018
    • 733020
    • 733022
    • 733024
    • 733026
    • 733028
    • 733030
    • 733032
    • 733034
    • 733036
    • 733038
    • 733040
    • 733042
    • 734030
    • 734032
    • 734034
    • 734036
Amount recalled
63,162

Where it was sold

Why it was recalled

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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 19, 2015 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.