Recall Z-1409-2021 ยท KJA Flask, Tissue Culture
OriGen Biomedical, Inc.
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
| Date | Apr 10, 2021 (initiated Jan 28, 2021) |
| Status | Terminated |
| Reason | It was identified that tissue culture bags were incorrectly labeled as free of phthalates. |
| Root cause | Labeling False and Misleading |
| Action | On 01/28/2021, Origen Biomedical, Inc. sent an "Technical Bulletin" via email to all affected consignees. On 4/12/21, the firm followed up a "Urgent: Medical Device Removal notification issued via E-Mail. In addition to informing consignees about the recall and technical bulletin, the The technical bulletin informed consignees about the following items: 1. Identify and quarantine any devices from the lots listed in this notice. 2. If affected product per Table 1 is identified, complete OriGens Material Return Authorization form (RD36), attached as Annex I to this notice. a. Leave the RMA |
| Quantity | 1201 units |
| Distribution | US: TX, LA, IA, NC, OH, NY, MA, MD, IL, PA, CA, KS, TN, RI, OR, FL, NJ, CT, Puerto Rico OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.