Z-0102-2019Class II

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr...

Name: Z-0102-2019 Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr...
Creator: OriGen Biomedical, Inc.
Published: 2018-08-21
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2018-08-21 / Terminated / root cause: sterility

FDA source

OriGen Biomedical, Inc. began a recall of Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO on 2018-08-21. FDA classified it as Class II and gives the reason as "The catheter failed the endotoxin testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0102-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-21
Posted: 2018-10-12
Terminated: 2021-10-05
Recalling firm: OriGen Biomedical, Inc.
Product: Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: The catheter failed the endotoxin testing.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: On 08/21/18, the firm emailed a recall notice to customers informing them of a nationwide recall of RDLC ECMO catheters. Customers were advised to return affected product to the firm. Customers with additional questions were advised to call 1-800-233-9014 or 1-512-474-7278. The firm also sent customers Technical Bulletin (TB) 1411 - Revision Feb 2018, Subject: Radiopacity of the Reinforced Dual Lumen Catheter (RDLC), Date: July 2015, and an Acknowledgment Receipt form to complete and return. On 09/12/18, and 09/20/18, the firm sent two additional recall notices, which included additional affected lot numbers that were not the subject of the current removal.
Quantity in commerce: 106
Distribution: US Nationwide in the states of NY, AR, MO, NC, GA, LA, CO, AL, MA, CA, MI, TX, OH, MD, FL, TN, SC, OR, AZ, UT, RI, SD, PA, NM, CT. Foreign (OUS): United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, Thailand
Product codes and lots: UDI: 00816203022059, lot N18687-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0102-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0102-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-12

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)