Home / Recalls / ORIGIO, Inc / Z-1946-2014

Z-1946-2014 Class II Terminated

Recalled by ORIGIO, Inc — Charlottesville, VA

Recall Details

Product Type: Devices
Report Date: July 9, 2014
Initiation Date: June 20, 2014
Termination Date: July 20, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511

Product Description

Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

Reason for Recall

Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration

Distribution Pattern

Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.

Code Information

CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.