FDA-Device2025-10-08Class II
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Hazard
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Sold states
US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC, ND, NJ, NY, OK, PA, TN, TX, VA, WA.
Affected count
28 units
Manufactured in
206 N Center Dr, N/A, North Brunswick, NJ, United States
Products
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0034-2026Want us to check the next one for you?
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