Drug recall
Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO)…
FDA recall event 87302 · Class III · OriGen Biomedical, Inc.
Key facts
| Event ID | 87302 |
|---|---|
| Recall numbers | Z-1409-2021 |
| Recalling firm | OriGen Biomedical, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. |
| Initiation date | Jan 28, 2021 |
| Report date | Apr 21, 2021 |
| Termination date | Apr 19, 2023 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000160256 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: