BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1094-2012 · Initiated November 28, 2011

    Recall

    Recall Number
    Z-1094-2012
    Event Number
    60824
    Firm
    ORIGIO HUMAGEN PIPETS INC.
    FEI Number
    1216677
    Product Code
    MQK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 28, 2011
    Posted
    February 23, 2012
    Terminated
    February 4, 2013
    Address
    2400 Hunters Way, Charlottesville, VA, 22911-7930

    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.

    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.

    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,

    Quantity

    73850 Cryopettes