Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
- 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:
- LeMaitre Vascular, Inc.
- Reason for Recall:
- The device was incorrectly packed in the wrong size labeled outer packaging.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Product Codes/Lot Numbers:
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
Distribution:
Distributed in: US, AR
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0289-2026
Related Recalls
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
LeMaitre Vascular
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).