Device recall
Z-1409-2021: Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is…
FDA device recall · Class III · OriGen Biomedical, Inc.
Key facts
| Recall number (Z-number) | Z-1409-2021 |
|---|---|
| Recall event | 87302 |
| 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… |
| Product code | KJA |
| Recalling firm | OriGen Biomedical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 19, 2023 |
| FEI number | 1000160256 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database