Recall Z-1089-2024— CooperSurgical, Inc.

Name: FDA recall Z-1089-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2023-12-20. It names one FDA 510(k) clearance: K142991. Product: global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.. Reason: The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-20
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K142991 — LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSALife Global Group, LLC·cleared 2015-02-17

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

global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.

Reason for recall

The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.

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