Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Vascutek, Ltd.
- Reason for Recall:
- Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Product Codes/Lot Numbers:
Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1912-2015
Related Recalls
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.