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Recall Observatory FDA recall evidence

Device product

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

Z-2337-2018

April 09, 2018

Class II

Product summary

Firm
Terumo Medical Corp
Event
Event 80242
Status
Terminated
Classification
Class II
Quantity
240
Official record key
device-enforcement:Z-2337-2018

Official wording

Reason: 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.

Code information: 5980075, 5980077

Distribution pattern: Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.