OriGen Biomedical, Inc. Recall 87302
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
OriGen Biomedical, Inc. Recall 87302 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1409-2021 |
| Event ID | 87302 |
| Event 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 |
| Product Type | Devices |
| Distribution | US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None |
| Quantity | 1201 units |
| Recall Reason | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. |
| Device Classification | 20210421 |
| Device Code Info | All Lots |
| Center Classification Date | 20210410 |
| Recall Initiation Date | 20210128 |
| Recalling Firm | OriGen Biomedical, Inc. |
| Initial Notification | |
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