Z-1409-2021Class III

Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin...

Name: Z-1409-2021 Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin...
Creator: OriGen Biomedical, Inc.
Published: 2021-01-28
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2021-01-28 / Terminated / root cause: labeling and UDI

FDA source

OriGen Biomedical, Inc. began a recall of 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... on 2021-01-28. FDA classified it as Class III and gives the reason as "It was identified that tissue culture bags were incorrectly labeled as free of phthalates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1409-2021
Classification: Class III
Status: Terminated
Initiated: 2021-01-28
Posted: 2021-04-10
Terminated: 2023-04-19
Recalling firm: OriGen Biomedical, Inc.
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
Product code: KJA Flask, Tissue Culture
Reason for recall: It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Root cause tag: labeling and UDI
FDA 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 # (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 ([email protected]). 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 ([email protected]). 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 [email protected] 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
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1409-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1409-2021	Class III	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-10

Product code KJA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)