Device product
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Z-0307-2024
Product summary
- Event
- Event 93267
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-0307-2024
Official wording
Reason: A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Code information: a) UDI/DI 20845357019169, Lot Numbers: 794-142-2, 794-142-4 b) UDI/DI 30845357019173, Lot Numbers: 794-142-3
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.