Z-0289-2026 Class II Ongoing
FDA device recall Z-0289-2026 was initiated by LeMaitre Vascular, Inc. on September 25, 2025 and is designated Class II. Reason for recall: The device was incorrectly packed in the wrong size labeled outer packaging. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2025
- Initiation Date
- September 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Artegraft¿ Collagen Vascular Graft; REF: AG1015;
Reason for Recall
The device was incorrectly packed in the wrong size labeled outer packaging.
Distribution Pattern
US distribution to the state of: AR
Code Information
REF: AG1015; UDI-DI: 00316837000343; Lot/Serial Number: 23MM581-016;