Artegraft vascular graft recalled over incorrect lot outer packaging labeling
LeMaitre Vascular is recalling one Artegraft Vascular Graft, REF AG740, because of a labeling mix-up resulting in the incorrect lot outer packaging of the product.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the fault is an incorrect lot on the outer packaging, and the source describes no defect in the graft itself.
Plain-English summary
LeMaitre Vascular, Inc. is recalling the Artegraft Vascular Graft, REF AG740. One unit was distributed in Illinois. The FDA has classified this recall as Class II.
The recall was initiated for a labelling mix-up resulting in the incorrect lot outer packaging of product. The source record does not describe a defect in the graft itself.
Affected product carries UDI-DI 00316837000299, serial number 24GG298-022, with an expiration date of 28 June 2027.
Facilities can identify affected product by the REF, UDI and serial number above, and may contact LeMaitre Vascular, Inc. for further information.
The recalled product
- Product
- Artegraft Vascular Graft; REF#: AG740;
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular graft
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- REF#: AG740
- UDI-DI: 00316837000299
- Serial Number: 24GG298-022
- Expiration Date: 28Jun2027
Distribution
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