ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE I

FDA device recall Z-1094-2012 · posted 2012-02-23 · Terminated

Recall details

Recalling firm

ORIGIO HUMAGEN PIPETS INC.

Reason for recall

Cryopettes were rupturing during the warming process following vitrification.

Action taken

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

Status

Terminated

Product code

MQK

Quantity affected

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,

Date initiated

2011-11-28

Date posted

2012-02-23

Date terminated

2013-02-04

Location

Charlottesville, VA

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