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
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:
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.
(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/