Recall Z-3296-2024— CooperSurgical, Inc.

Name: FDA recall Z-3296-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-16

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2024-02-16. It names one FDA 510(k) clearance: K153267. Product: Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A. Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-02-16
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K153267 — ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S·cleared 2016-07-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.