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
731030731032731034731036731038731206731218731220731222731224731226731228731407731506731507731508731509731510731512731514731516731608731809732010732030732032732034732038732211732412732518732520732522732524732526732528733006733007733008733010733012733014733016733018733020733022733024733026733028733030733032733034733036733038733040733042734030734032734034734036
- 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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