LeMaitre Vascular, Inc.: Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- LeMaitre Vascular, Inc.
- Product
- Artegraft¿ Collagen Vascular Graft; REF: AG1015;
- Reason / hazard
- The device was incorrectly packed in the wrong size labeled outer packaging.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution to the state of: AR
- Recall initiated
- 2025-09-25
- Code info
- REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;
- Product quantity
- 1 unit
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Brunswick
- State
- NJ
- Country
- United States
- Event id
- 97700
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