HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 1120090850 1120109758 1120080956 1120074392 1120099148 1137597566 1137603753 1183458035
  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:
Maquet Cardiovascular, LLC
Reason for Recall:
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Product Codes/Lot Numbers:

Serial Numbers: 1120090850 1120109758 1120080956 1120074392 1120099148 1137597566 1137603753 1183458035

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1868-2020

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