Device product
LYFO-DISK, P. venetum, Catalog number 0794L
Z-0308-2024
Product summary
- Event
- Event 93267
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0308-2024
Official wording
Reason: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Code information: UDI/DI 10845357019186, Lot Numbers: 794-142-1
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
Derived failure modes
-
Unknown
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.