Z-1324-2012

Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook...

Name: Z-1324-2012 Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook...
Creator: Cook, Inc.
Published: 2012-02-15
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2012-02-15 / Terminated / root cause: manufacturing process

FDA source

Cook, Inc. began a recall of 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... on 2012-02-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1324-2012
Status: Terminated
Initiated: 2012-02-15
Posted: 2012-03-28
Terminated: 2012-07-03
Recalling firm: Cook Incorporated
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.
Product code: MQL Media, Reproductive
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.
Root cause tag: manufacturing process
FDA 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: [email protected]. 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.
Product codes and lots: Lot A895473 (K-SICO-50) and Lot A895499 (K-SICO-200).

Product code MQL

K022002Class IISydney Ivf Culture OilCook Urological, Inc. / cleared 2002-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)