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Terumo Medical Corp recalls Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Recalled July 11, 2018 · FDA recall Z-2337-2018 · Terumo Medical
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. · FDA Class II
Units
240
Sold at
Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
Description
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.
Product
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Manufacturer(s)
Terumo Medical Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →