FDA-Device2021-04-21Class III
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
OriGen Biomedical, Inc.
Hazard
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Sold states
US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None
Affected count
1201 units
Manufactured in
7000 Burleson Rd Bldg D, N/A, Austin, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2021Don't want to check this manually?
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