Class 2 Device Recall Sydney IVF Culture Oil

• Date Initiated by Firm: February 15, 2012
• Date Posted: March 28, 2012
• Recall Status: Terminated on July 03, 2012
• Recall Number: Z-1324-2012
• Recall Event ID: 61177
• 510(K)Number: K022002
• Product Classification: Media, reproductive - Product Code MQL
• 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.
• Code Information: Lot A895473 (K-SICO-50) and Lot A895499 (K-SICO-200).
• Recalling Firm/ Manufacturer: Cook, Inc.; 750 Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Julie Cooper; 800-457-4488 Ext. 7241
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MQL