Angio-Seal Evolution Vascular Closure Device recall
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Why was Angio-Seal Evolution Vascular Closure Device 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5980075, 5980077
- Product
- Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
- Recalling firm
- Terumo Medical Corp
- Quantity
- 240
- Distribution
- Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
- Recall date
- July 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)