Device Recall Cryopette

  • Modèle / numéro de série
    Lot numbers/Expiration: 27109A exp. 9/2011; 29909A, exp. 10/2011; 06210A, exp. 3/2012; 06210B, exp. 3/3/2012; 16210A, exp. 6/2012; 20810A, exp. 7/2012; 22410A, exp. 8/2012; 25610A, exp. 9/2012; 32010A, exp. 11/2012; 32010B, exp. 11/2012; 35510A, exp. 12/2012; 03210A, exp. 2/2012; 05411A, exp. 2/2013; 09811C, exp. 4/2013; 09811A, exp. 4/2013; 09811B, exp. 4/2013; 14611A, exp. 5/2013; 14611B, exp. 2013; 020111, exp. 8/1/13; 020111, exp. 8/8/13; 020111, exp. 8/15/13; 020111, exp. 9/5/13; 020111, exp. 9/12/13; 020111, exp. 9/26/13
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - U.S. included states of AL, AR, DE, PR, NY, MA, NH, VT, IL, CT, NJ, PA, VA, WV, NV, NC, SC, GA, FL, OH, MD, MS, IN, MI, PR, WI, MN, SD, MT, MO, TX, CO, UT, AZ, CA, HI, OR, AK, WA and in countries of Turkey, Saudi Arabia, Kuwait, Jordon, So. Korea, Taiwan, Brazil, So. Africa, Oman, Kazakhstan, Honduras, Slovenia, Serbia, Poland, Czech Republic, Romania, Croatia, Ukraine, Netherlands, Bulgaria, Hungary, Russia, Lebanon, Singapore, Malaysia, Vietnam, China, Thailand, Nigeria, Japan, Spain, Greece, Canada, Denmark, France, United Kingdom, Italy, Germany, and Australia,
  • Description du dispositif
    ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 22911 www.origio.com || The Cryopette (r) is a cryopreservative storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    ORIGIO HUMAGEN PIPETS INC., 2400 Hunters Way, Charlottesville VA 22911-7930
  • Source
    USFDA