Z-1456-2015Class I

OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by...

Name: Z-1456-2015 OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by...
Creator: OriGen Biomedical, Inc.
Published: 2015-03-30
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2015-03-30 / Terminated

FDA source

OriGen Biomedical, Inc. began a recall of OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual... on 2015-03-30. FDA classified it as Class I and gives the reason as "Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1456-2015
Classification: Class I
Status: Terminated
Initiated: 2015-03-30
Posted: 2015-04-23
Terminated: 2016-05-03
Recalling firm: OriGen Biomedical, Inc.
Product: OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
FDA root cause: Mixed-up of materials/components
Action: The firm, OriGen, sent an "URGENT; MEDICAL DEVICE RECALL" letter dated 3/30/2015 and response form to all consignees via e-mail. The conisgnees were notified on 3/31/15 and 4/1/15. The recalling firm also posted a recall notification on the ELSO website, which is a public site mainly used by professionals within the ECMO community and press release dated 4/15/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to discontinue use of all OriGen W13F Reinforced Dual Lumen ECMO Catheters from the lot; immediately return any unused product to OriGen Biomedical; and complete and return the attached acknowledgement and receipt form even if you do not currently have product in your inventory. The firm recommends that the consignee use an alternate product in the interim. If you have any questions regarding the return of product that you have on hand or the status of the investigation, please do not hesitate to conact the company at: OriGen Biomedical, Attn: Director, Quality and Regulatory Affairs, 7000 Burleson Rd, Bldg D, Austin, TX 78744 or call +1 512 474 7278 CST Monday-Friday 8:00-5:00.
Quantity in commerce: 51 units
Distribution: Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.
Product codes and lots: Lot N18549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1456-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1456-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-23

Product code DWF

K113869Class IIOrigen Reinforced Dual Lumen CatheterOrigen Biomedical, Inc. / cleared 2012-07-26

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)