Recall Z-1094-2012 ยท MQK Labware, Assisted Reproduction
ORIGIO HUMAGEN PIPETS INC.
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.
| Date | Feb 23, 2012 (initiated Nov 28, 2011) |
| Status | Terminated |
| Reason | Cryopettes were rupturing during the warming process following vitrification. |
| Root cause | Device Design |
| 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 labora |
| Quantity | 73850 Cryopettes |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100596 | CRYOPETTE Mid-Atlantic Diagnostics, Inc., Dec 6, 2010 |