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.

FDA Recall Z-1094-2012 · Posted 2012-02-23

Recalling FirmORIGIO HUMAGEN PIPETS INC.

Recall StatusTerminated

Product CodeMQK

Date Initiated2011-11-28

Date Terminated2013-02-04

Product Quantity73850 Cryopettes

Reason for Recall

Cryopettes were rupturing during the warming process following vitrification.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100596CRYOPETTEMid-Atlantic Diagnostics, Inc. · 2010-12-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.