Device product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Z-3297-2024
Product summary
- Event
- Event 95246
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2680 units
- Official record key
device-enforcement:Z-3297-2024
Official wording
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development
Code information: UDI: 20888937816543 Lot 230922-018008 Expiration date: 20 September 2024
Distribution pattern: Worldwide distribution - US Nationwide.
Derived failure modes
-
Unknown
Low concentration of sodium pyruvate in the wash could compromise gamete development