U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Media, reproductive - Product Code MQL
원인
Cook medical is recalling sydney ivf culture oil due to a number of recent customer complaints that have identified it as a possible cause of embryo degeneration at day 5/6.
조치
Cook Medical sent an Urgent Recall Notices letter dated February 15, 2012 to all affected customers. The letter identified the recall product, reason for the recall and actions to be taken. The notice included directions to pull the recalled product from stock, isolate it and forward the notice to any sub-accounts. Customers were requested to complete and return the recall acknowlegement and product tracking form by to Fax: 812-829-1801 or Email: julie.cooper@cookmedical.com. For questions call 800-457-4448 x7241.
Worldwide Distribution - USA (nationwide) including the states of IL, KS, KY, MA, NJ. TN, TX, UT, VA, WI, WV, and the country of Barbados.
제품 설명
Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, || Product Usage: || Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations.