Device product
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W
Z-1337-2023
Product summary
- Event
- Event 91764
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 235 units
- Official record key
device-enforcement:Z-1337-2023
Official wording
Reason: Some batches of product were not sterilized to their minimum sterilization specification.
Code information: UDI-DI: 00607567700345; Lot Numbers: 3000274687
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Brazil, China.
Derived failure modes
-
Unknown
Some batches of product were not sterilized to their minimum sterilization specification.