FDA-Device2025-10-29Class IIMISBRANDING

Artegraft¿ Collagen Vascular Graft; REF: AG1015;

LABEL MIX UPARMedical devices
Hazard

The device was incorrectly packed in the wrong size labeled outer packaging.

Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to the state of: AR
Affected count
1 unit
Manufactured in
206 N Center Dr, North Brunswick, NJ, United States
Products
Artegraft¿ Collagen Vascular Graft; REF: AG1015;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0289-2026

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