Devices

Device Recall Sydney IVF Culture Oil

  • Model / Serial
    Lot A895473 (K-SICO-50) and Lot A895499 (K-SICO-200).
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Cook, Inc.
  • 1 Event

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA