The Food and Drug Administration (FDA) has announced that OriGen Biomedical has initiated a nationwide recall of one lot of its VV13F Reinforced Dual Lumen ECMO Catheters. The catheters’ clear extension tube could possibly separate from where it is inserted in the hub. This could lead to the treatment/intervention being rendered ineffective.
The term Extra-Corporeal Membrane Oxygenation means “heart-lung bypass,” in which a machine outside the body will take over the heart’s function in order to provide enough oxygen through blood circulation, so that the lungs and heart could rest and heal.
ECMO treatment is used in very young infants with a heart or breathing problem, in cases where the condition is considered reversible. It may also be used in infants who are very ill and are awaiting a heart or lung transplant.
The following are the details on lot number, date of manufacture, and expiration of the recalled ECMO product:
Lot N18549, 238 Units
Manufactured 09/2014, distributed Feb 16- March 26, 2015
Expiration 09/2018
Distributed to ECMO sites in California, Michigan, Ohio, Oregon, Texas, Indiana, New York, Florida, Pennsylvania, Hawaii, Kentucky
According to the FDA, “The OriGen VV13F Reinforced Dual Lumen ECMO Catheters is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less in Neonatal Intensive Care and Pediatric Intensive Care ECMO centers.”
Thus far, it has been reported that there was one serious adverse event, resulting in serious patient injury.
Customers are requested to return any product from OriGen of the above-mentioned lot to the company. The contact details are given below:
OriGen Biomedical
Attn: Bernie R Silvers
7000 Burleson Rd, Bldg. D
Austin, TX 78744
Monday – Friday 8:00-5:00 (CST)
Telephone: 512 474 7278
Customers could also report adverse events to FDA by calling 1-800-332-1088, by fax at 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.
References:
(2015 Apr 15). OriGen Biomedical Issues Nationwide Recall of OriGen VV13F Reinforced Dual Lumen ECMO Catheters. Retrieved from http://www.fda.gov/Safety/Recalls/ucm443009.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Kaneshiro, N.K. (2014 Feb 26). Extracorporeal membrane oxygenation. Retrieved from http://www.nlm.nih.gov/medlineplus/ency/article/007234.htm
Introduction to ECMO for Parents. Retrieved from https://lane.stanford.edu/portals/cvicu/HCP_CV_Tab_1/ecmo_for_parents.pdf
(2013 Dec). What is Cardiopulmonary Bypass? Retrieved from http://www.cincinnatichildrens.org/health/c/bypass/
and connect with fellow professionals
At DoveMed, our utmost priority is your well-being. We are an online medical resource dedicated to providing you with accurate and up-to-date information on a wide range of medical topics. But we're more than just an information hub - we genuinely care about your health journey. That's why we offer a variety of products tailored for both healthcare consumers and professionals, because we believe in empowering everyone involved in the care process.
Our mission is to create a user-friendly healthcare technology portal that helps you make better decisions about your overall health and well-being. We understand that navigating the complexities of healthcare can be overwhelming, so we strive to be a reliable and compassionate companion on your path to wellness.
As an impartial and trusted online resource, we connect healthcare seekers, physicians, and hospitals in a marketplace that promotes a higher quality, easy-to-use healthcare experience. You can trust that our content is unbiased and impartial, as it is trusted by physicians, researchers, and university professors around the globe. Importantly, we are not influenced or owned by any pharmaceutical, medical, or media companies. At DoveMed, we are a group of passionate individuals who deeply care about improving health and wellness for people everywhere. Your well-being is at the heart of everything we do.
0 Comments
Please log in to post a comment.