global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult
FDA device recall Z-1089-2024 · posted 2024-02-14 · Open, Classified
Recall details
- Recalling firm
- CooperSurgical, Inc.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MQL
- Quantity affected
- 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 countrie
- Date initiated
- 2023-12-20
- Date posted
- 2024-02-14
- Location
- Trumbull, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA (K142991) | Life Global Group, LLC | 2015-02-17 |