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
Z-1409-2021
Product summary
- Event
- Event 87302
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1201 units
- Official record key
device-enforcement:Z-1409-2021
Official wording
Reason: It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Code information: All Lots
Distribution pattern: US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None
Derived failure modes
-
Labeling or packaging
incorrectly labeled