Medical Device Recall: 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.
CooperSurgical, Inc. · December 20, 2023
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
994 total (481 US; 513 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1089-2024
Status: ongoing
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