Reported Jul 11, 2018 · Terminated

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

Terumo Medical Corp.

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: Terumo Medical Corp · 2101 Cottontail Ln · Somerset, NJ · 08873-1277

Is this the product you have?

  • Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Lot codes and dates
    • 5980075
    • 5980077
Amount recalled
240

Where it was sold

Why it was recalled

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.

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 Apr 19, 2019 · Data as of Sep 19, 5:32 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.