Events

Retiro De Equipo (Recall) de Device Recall Cryopette

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ORIGIO HUMAGEN PIPETS INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60824
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1094-2012
  • Fecha de inicio del evento
    2011-11-28
  • Fecha de publicación del evento
    2012-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106579
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Labware, assisted reproduction - Product Code MQK
  • Causa
    Cryopettes were rupturing during the warming process following vitrification.
  • Acción
    ORIGIO sent a Field Safety Corrective Action letter dated November 21, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ORIGIO feels it is important to eliminate this risk completely. As soon as we are confident that this danger of rupture has been eliminated, we will make Cryopettes available again. Please use the attached UPS call tag to return any unused Cryopettes to ORIGIO Inc. Upon receipt, we will issue a credit to your account. We sincerely apologize for the problems this issue has caused in your laboratories. For further questions please call (434) 979-4000.

Device

Device Recall Cryopette
  • Modelo / Serial
    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
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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,
  • Descripción del producto
    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
    ORIGIO HUMAGEN PIPETS INC.

Manufacturer

ORIGIO HUMAGEN PIPETS INC.
  • Dirección del fabricante
    ORIGIO HUMAGEN PIPETS INC., 2400 Hunters Way, Charlottesville VA 22911-7930
  • Source
    USFDA