🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: April 9, 2018 Terumo Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    5980075, 5980077
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Terumo Medical Corp
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

5980075, 5980077

Distribution:

Distributed in: AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2337-2018

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