Device product
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Z-1961-2025
Product summary
- Event
- Event 96965
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4,882 units
- Official record key
device-enforcement:Z-1961-2025
Official wording
Reason: Lack of sterility assurance.
Code information: Model/Catalog Number: 205000DS; UDI No. 10381780000112; All lots.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Taiwan (Province of China), Viet Nam, Brazil, Trinidad and Tobago, El Salvador, South Korea, Peru, Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Israel, Italy, Kenya, Slovenia, South Africa, Spain, Sweden, Switzerland and United Kingdom.
Derived failure modes
-
Sterility assurance
Lack of sterility