Z-0269-2019Class I

REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473

Name: Z-0269-2019 REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473
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 REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a... 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-0269-2019
Classification: Class I
Status: Terminated
Initiated: 2015-03-30
Posted: 2018-11-07
Terminated: 2024-03-01
Recalling firm: OriGen Biomedical, Inc.
Product: REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial 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: On April 1, 2015 the firm sent an MEDICAL DEVICE MARKET WITHDRAWAL to customers/distributors via email to inform them the catheters may start to show signs of failure at the junction of the clear extension tube and blue hub connection that can be recognized by air entrainment or blood leakage. If the preliminary failure is identified, the catheter should be replaced immediately. Serious injuries could occur due to the failure mode. The customers are instructed to discontinue use of all products from the affected lot and to return any unused products immediately and to complete and return the acknowledgement and receipt form even if the customer does not currently have products in its inventory. The firm is conducting an investigation to determine root cause of the failure and will notify the customers when the investigation has been completed and when replacement products are available. If customers have any questions regarding the return of product or the status of the investigation, they can contact: OriGen Biomedical Attn: Bernie R Silvers 7000 Burleson Road, Building D Austin, TX 78744 Phone Number +1 512-474-7278
Quantity in commerce: 134
Distribution: Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, NC, NY, OH, OR, PA, RI, TX, WA, and WI OUS: Belgium, Canada, Germany, Kingdom of Saudi Arabia, Poland, Spain Sweden, Thailand and United Kingdom
Product codes and lots: Product Code UDI Lot VV19F 00816203022097 N18394

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2019	Class I	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07

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)