Collagen vascular graft recalled after being packed in wrong size packaging
LeMaitre Vascular is recalling one Artegraft Collagen Vascular Graft that was incorrectly packed in outer packaging labeled for a different size.
What this means for you
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: Scored 2 under the labeling-error criterion: the record describes an outer package labeled for the wrong size, with no hazard or reported harm stated.
Plain-English summary
The Artegraft Collagen Vascular Graft, REF AG1015, is being recalled because the device was incorrectly packed in the wrong size labeled outer packaging.
The recall covers one unit carrying UDI-DI 00316837000343, lot/serial number 23MM581-016, distributed in Arkansas. The FDA has classified the action as Class II.
The enforcement record describes the packaging mismatch and does not state any injury or clinical consequence. The facility holding the affected serial number should verify the graft against the outer label rather than relying on it, and follow LeMaitre's instructions.
The recalled product
- Product
- Artegraft¿ Collagen Vascular Graft; REF: AG1015;
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular graft
- Hazard
- mislabeling
- wrong-size
- packaging-error
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 (3)
- REF: AG1015
- UDI-DI: 00316837000343
- Lot/Serial Number: 23MM581-016
Distribution
Distributed in 1 state:
- AR
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