OriGen Biomedical, Inc. recalls Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and cont…

Recall date

January 28, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1409-2021

FDA classification

Class III

Brand / firm

OriGen Biomedical, Inc.

Sold / distributed

US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None

Why it was recalled

It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps