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
59800755980077
- 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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