Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters

For Immediate Release

September 27, 2017

Contact

Consumers

Jackie Jaskula
j.jaskula@origen.com
1-512-474-7278
 

Announcement

On August 2, 2017, OriGen Biomedical initiated a recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters.

Customers who have received product from either of these lots of VV28F Reinforced Dual Lumen ECMO Catheters should return any product that they currently have to OriGen Biomedical.

OriGen VV28F Reinforced Dual Lumen ECMO Catheters described below have been recalled:

Catalog numberLot numberManufacture dateExpiration date
VV28FN18487August 14, 2014August 30, 2018
VV28FN18487-1April 15, 2015April 30, 2019

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 (USA) or less than 29 days (rest of world).

OriGen Biomedical voluntarily recalled OriGen VV28F Reinforced Dual Lumen ECMO Catheters Lot N18487 and N18487-1 after becoming aware of a reported adverse event. OriGen Biomedical has notified the FDA of this action.OriGen Biomedical is aware of two (2) product failures and has received a complaint associated with each of the two (2) product failures.  A recurrence of this event could result in serious patient injury.

OriGen Biomedical is notifying distributors and user facilities by e-mail and is arranging for return of all recalled product.

Users within the USA may report adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.

The recalled product was distributed to user facilities in the following USA states:

AlabamaArkansasArizona
CaliforniaConnecticutFlorida
GeorgiaIllinoisIndiana
MichiganMissouriNew York
OhioOklahomaOregon
Rhode IslandSouth DakotaTexas
TennesseeWashingtonWisconsin

The recalled product was sold to distributors in the following countries outside the USA:

Lot Number

Country

N18487Austria
Belgium
Chile
Czech Republic
Italy
Kingdom of Saudi Arabia
Netherlands
Poland
SWEDEN
Thailand
USA
N18487-1Chile
Colombia
India
Kingdom of Saudi Arabia
South Africa
United Arab Emirates
USA

Consumers with questions may contact OriGen Biomedical at:

OriGen Biomedical Attn: Jackie Jaskula
7000 Burleson Rd, Bldg. D Austin, TX USA 78744

CST Monday – Friday 8:00-5:00 Phone: +1 512 474 7278

Fax: +1 512 617 1503
e-mail: j.jaskula@origen.com

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Page Last Updated: 03/21/2018
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