FDA-Device2018-07-11Class II
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Terumo Medical Corp
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.
Sold states
Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
Affected count
240
Manufactured in
2101 Cottontail Ln, Somerset, NJ, United States
Products
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2337-2018Don't want to check this manually?
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