FDAFDA · Food and drugs·Recall number Z-1089-2024
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.
Published February 21, 2024 · Recall initiated: December 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CooperSurgical, Inc.
- Distributor
- Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WV and the countries of Canada, Brazil, Mexico, Argentina, Hong Kong, Japan, Turkey, Netherlands, Belgium, Spain, Taiwan, United Kingdom, Austria, Georgia, France, Denmark, Greece, Saudi Arabia, Thailand, New Zealand, Estonia, Poland, Jordan, and Germany.
- Lot
- LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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