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  4. OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters
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COMPANY ANNOUNCEMENT

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

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.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
Due to potential product failures
Company Name:
OriGen Biomedical
Brand Name:
Brand Name(s)
OriGen
Product Description:
Product Description
Catheters

Company 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 number Lot number Manufacture date Expiration date
VV28F N18487 August 14, 2014 August 30, 2018
VV28F N18487-1 April 15, 2015 April 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.

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, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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

Alabama Arkansas Arizona
California Connecticut Florida
Georgia Illinois Indiana
Michigan Missouri New York
Ohio Oklahoma Oregon
Rhode Island South Dakota Texas
Tennessee Washington Wisconsin

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

Lot Number

Country

N18487 Austria
Belgium
Chile
Czech Republic
Italy
Kingdom of Saudi Arabia
Netherlands
Poland
SWEDEN
Thailand
USA
N18487-1 Chile
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

 
 

Company Contact Information

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