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

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Announcement

On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage.

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:

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.

OriGen Biomedical voluntarily recalled OriGen W28F 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 two (2) complaints associated with the problem. 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.

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

Consumers with questions may contact OriGen Biomedical at:

OriGen Biomedical Attn: Jackie Jaskula
7000 Burleson Rd, Bldg. D Austin, TX 78744
CST Monday - Friday 8:00-5:00 Phone: +1512 474 7278
Fax: +1512 617 1503
e-mail: [email protected]

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.

• Online at http://www.fda.gov/safety/medwatch/howtoreport/default.htm
  (form available to fax or mail), or
• Call FDA 1-800-FDA-1088