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FDAApril 9, 2018device

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

What to do

FDA enforcement status: Terminated

Brands named

terumo medicalterumo

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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