Z-1228-2019Class I

ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F

Name: Z-1228-2019 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
Creator: OriGen Biomedical, Inc.
Published: 2017-01-17
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2017-01-17 / Terminated / root cause: manufacturing process

FDA source

OriGen Biomedical, Inc. began a recall of ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F on 2017-01-17. FDA classified it as Class I and gives the reason as "Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1228-2019
Classification: Class I
Status: Terminated
Initiated: 2017-01-17
Posted: 2019-06-04
Terminated: 2021-07-27
Recalling firm: OriGen Biomedical, Inc.
Product: ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/17/2017, Technical Bulletin 17.01 was mailed to customers. Customers were informed to clamp all sizes of catheters only in the middle. The following contact information was provided: US: 1-512-474-7278, and Germany: +49-7475-915591.
Quantity in commerce: 72
Distribution: US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
Product codes and lots: Lots: N18431, N18431-1, R19280, R19281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1228-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1227-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1228-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1229-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1230-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1231-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1232-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

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)