FDAHealthSeptember 25, 2025
LeMaitre Vascular, Inc. — Artegraft¿ Collagen Vascular Graft; REF: AG1015;
⚠️ The device was incorrectly packed in the wrong size labeled outer packaging.
Is this relevant to me?
- Geography
- US, AR
- Source agency
- FDA
- Category
- Health
- Published
- September 25, 2025
US distribution to the state of: AR
What's affected?
- Product
- Artegraft¿ Collagen Vascular Graft; REF: AG1015;
- Lot code
- /Serial
Additional details
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1 unit.
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