Events

Rappel de Device Recall Cryopette

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par ORIGIO HUMAGEN PIPETS INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60824
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1094-2012
  • Date de mise en oeuvre de l'événement
    2011-11-28
  • Date de publication de l'événement
    2012-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106579
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Labware, assisted reproduction - Product Code MQK
  • Cause
    Cryopettes were rupturing during the warming process following vitrification.
  • Action
    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
  • 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
    Obstetrical and Gynecological Devices
  • 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
    ORIGIO HUMAGEN PIPETS INC.

Manufacturer

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