Moderate riskFDA DeviceClass II

LeMaitre Vascular Artegraft Vascular Graft recalled for incorrect lot labeling

LeMaitre Vascular is recalling one unit of Artegraft Vascular Graft (Model AG740) distributed in Illinois due to a labeling mix-up on the outer packaging. The product box was labeled with an incorrect lot number, which could cause confusion during clinical use. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received or used this product (Serial Number 24GG298-022, expiring 28 Jun 2027), contact LeMaitre Vascular immediately
  2. Do not use the affected unit until you verify the correct lot number with the manufacturer
  3. Check your inventory records if you work in a healthcare facility in Illinois

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Artegraft Vascular Graft; REF#: AG740;
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
1 unit
Illnesses reported
None reported
Manufactured in
206 N Center Dr, N/A, North Brunswick, NJ, United States
Classification
Class II
Recall number
Z-1574-2026

In the FDA's words

Description
Artegraft Vascular Graft; REF#: AG740; Labeling mix-up resulting in the incorrect lot outer packaging of product. REF#: AG740; UDI-DI: 00316837000299; Serial Number: 24GG298-022; Expiration Date: 28Jun2027; Distribution: US Nationwide distribution in the state of IL. Affected quantity: 1 unit
Hazard
Labeling mix-up resulting in the incorrect lot outer packaging of product.

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