Class 3 Device Recall Evolve Cell Culture Bags

• Date Initiated by Firm: January 28, 2021
• Date Posted: April 10, 2021
• Recall Status: Terminated on April 19, 2023
• Recall Number: Z-1409-2021
• Recall Event ID: 87302
• Product Classification: Flask, tissue culture - Product Code KJA
• 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
• Code Information: All Lots
• Recalling Firm/ Manufacturer: OriGen Biomedical, Inc.; 7000 Burleson Rd Bldg D; Austin TX 78744-3202
• For Additional Information Contact: Brittney Bender; 512-474-7278
• Manufacturer Reason for Recall: It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
• FDA Determined 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 # (assigned by OriGen to Customer) blank b. In Reason for Return: section, please write FA_2020_001 3. Send the RD36 form to OriGen Customer Service (info@origenbio.com). OriGen Customer Service will provide a return label, an RMA# to enter on the RD36 form, and will issue a credit for the product. 4. Appropriately package the rejected product and return to OriGen using the supplied return label. 5. Please complete the Field Action Customer Reply Form attached as Annex II to this notice, scan and send to OriGen Customer Service (info@origenbio.com). Please complete this form even if you do not have any affected product. 6. This information and instruction must be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred and remain unused. 7. If you should have any questions or concerns regarding this field notice, please contact Richard Martin, Recall Coordinator, at d.martin@origenbio.com or at 512-474-7278. 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.