FDA Medical Device Recalls (openFDA)
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 reduce pH fluctuations.
- Recall number
- Z-1324-2012
- Recalling firm
- Cook, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-02-15
- Posted
- 2012-03-28
- Terminated
- 2012-07-03
- 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.
- Lot, serial or model codes
- Lot A895473 (K-SICO-50) and Lot A895499 (K-SICO-200).
- 510(k) numbers
- ["K022002"]
- PMA numbers
- not on file
- Product code
- MQL
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28