—#107466

Product

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.

FDA product code: MQL — Media, Reproductive
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K022002
Affected lot / code info: Lot A895473 (K-SICO-50) and Lot A895499 (K-SICO-200).

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) including the states of IL, KS, KY, MA, NJ. TN, TX, UT, VA, WI, WV, and the country of Barbados.

Timeline

Recall initiated: 2012-02-15
Posted by FDA: 2012-03-28
Terminated: 2012-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.