Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and conta

FDA device recall Z-1409-2021 · posted 2021-04-10 · Terminated

Recall details

Recalling firm

OriGen Biomedical, Inc.

Reason for recall

It was identified that tissue culture bags were incorrectly labeled as free of phthalates.

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KJA

Quantity affected

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

Date initiated

2021-01-28

Date posted

2021-04-10

Date terminated

2023-04-19

Location

Austin, TX