Device product
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Z-1336-2023
Product summary
- Event
- Event 91764
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2300 units
- Official record key
device-enforcement:Z-1336-2023
Official wording
Reason: Some batches of product were not sterilized to their minimum sterilization specification.
Code information: UDI-DI: 00607567700406; Lot Numbers: 3000278401, 3000271148, 3000268643, 3000263026, 3000274504, 3000263925
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.