Events

Recall of Device Recall Cryopette

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ORIGIO HUMAGEN PIPETS INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60824
  • Event Risk Class
    Class 2
  • Event Number
    Z-1094-2012
  • Event Initiated Date
    2011-11-28
  • Event Date Posted
    2012-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106579
  • Notes / Alerts
    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.
  • Extra notes in the data
    Labware, assisted reproduction - Product Code MQK
  • Reason
    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
  • Model / 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
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    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,
  • Product Description
    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.
  • Manufacturer Address
    ORIGIO HUMAGEN PIPETS INC., 2400 Hunters Way, Charlottesville VA 22911-7930
  • Source
    USFDA