Recall Z-1089-2024
CooperSurgical, Inc. · initiated December 20, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743
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 taken
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.
Details
- Recall number
- Z-1089-2024
- Initiated
- December 20, 2023
- Posted by FDA
- February 14, 2024
- Product code
- MQL – Media, Reproductive
- Quantity
- 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…
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT