FDA-Device2014-07-09Class II

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

ORIGIO, Inc
Hazard

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

Sold states
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.
Affected count
Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511
Manufactured in
2400 Hunters Way, Charlottesville, VA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2014

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