Class 2 Device Recall global Medium

• Date Initiated by Firm: December 20, 2023
• Date Posted: February 14, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1089-2024
• Recall Event ID: 93688
• 510(K)Number: K142991
• Product Classification: Media, reproductive - Product Code MQL
• 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.
• 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
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 95 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Customer Service; 203-601-9818
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On December 13, 2023, the firm notified customers via Urgent Media Recall Field Safety Notice letters. Customers were instructed to quarantine affected product and respond to the recall notice. The firm will arrange for the return of affected product and customers will receive credit for returned affected product. If you have additional questions, please email CooperSurgical Recall at recall@coopersurgical.com. Alternately, please contact a CooperSurgical Product Surveillance representative at +1 203.601.5200 Ext. 3300.
• Quantity in Commerce: 994 total (481 US; 513 OUS)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MQL