FDA recall Z-1336-2023

Maquet Cardiovascular, LLC · Class II · device

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Brazil, China.

Key facts

Status
Ongoing
Initiation date
2023-03-06
Report date
2023-04-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

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