FDA recall Z-3298-2024

CooperSurgical, Inc. · Class II · device

Product

Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

Reason for recall

Low concentration of sodium pyruvate in the wash could compromise gamete development

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status
Ongoing
Initiation date
2024-02-16
Report date
2024-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3298-2024