FDA recall Z-3296-2024

Product

Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

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-3296-2024