FDA recall Z-1409-2021

OriGen Biomedical, Inc. · Class III · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-01-28
Report date
2021-04-21
Termination date
2023-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2021