Recall Z-1409-2021— OriGen Biomedical, Inc.
Class III · Terminated
Class III FDA medical device recall by OriGen Biomedical, Inc., initiated 2021-01-28, terminated 2023-04-19. FDA's recall record names no specific 510(k) clearance for this event. 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: It was identified that tissue culture bags were incorrectly labeled as free of phthalates..
- Recalling firm
- OriGen Biomedical, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-01-28
- Terminated
- 2023-04-19
- Firm location
- Austin, TX, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.