FDA-Device2023-04-12Class II

VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Maquet Cardiovascular, LLC
Hazard

Some batches of product were not sterilized to their minimum sterilization specification.

Sold states
Worldwide distribution - US Nationwide and the countries of Brazil, China.
Affected count
2300 units
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1336-2023

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