Recall Z-1089-2024 ยท MQL Media, Reproductive
CooperSurgical, Inc.
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.
| Date | Feb 14, 2024 (initiated Dec 20, 2023) |
| Status | Open, Classified |
| 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. |
| Root 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 | 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, Taiwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA Life Global Group, LLC, Feb 17, 2015 |