Recall Z-1324-2012 ยท MQL Media, Reproductive
Cook, Inc.
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
| Date | Mar 28, 2012 (initiated Feb 15, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 54 total from both lots |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of IL, KS, KY, MA, NJ. TN, TX, UT, VA, WI, WV, and the country of Barbados. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022002 | SYDNEY IVF CULTURE OIL Cook Urological, Inc., Aug 12, 2002 |