Z-1409-2021 Class III Terminated
FDA device recall Z-1409-2021 was initiated by OriGen Biomedical, Inc. on January 28, 2021 and is designated Class III. Reason for recall: It was identified that tissue culture bags were incorrectly labeled as free of phthalates. The recall status is terminated (terminated April 19, 2023). Affected quantity: 1201 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- January 28, 2021
- Termination Date
- April 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1201 units
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.
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
Code Information
All Lots