FDA Enforcement
Class II
Ongoing
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Recall: Z-3297-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3297-2024
- Event ID
- 95246
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CooperSurgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- February 16, 2024
- Classification Date
- September 26, 2024
- Address
- 95 Corporate Dr, Trumbull, CT, 06611-1350, United States
Description
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Reason
Low concentration of sodium pyruvate in the wash could compromise gamete development
Code Info
UDI: 20888937816543 Lot 230922-018008 Expiration date: 20 September 2024
Distribution
Worldwide distribution - US Nationwide.
Quantity
2680 units