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Recall Observatory FDA recall evidence

Device 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.

Z-1089-2024

December 20, 2023

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 93688
Status
Ongoing
Classification
Class II
Quantity
994 total (481 US; 513 OUS)
Official record key
device-enforcement:Z-1089-2024

Official wording

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.

Code information: LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.