OriGen Catheter Recall Issued After Reports of Failures Putting Patients At Risk
Following reports of product failure, a recall as been issued for certain catheters manufactured and sold by OriGen Biomedical that are used during life support procedures.
The OriGen catheter recall was announced by the FDA on September 27, after the company became aware of at least two adverse events which impacted patients. In both cases, the company reports that the catheters failed, but did not give details about the cause of the problems or impact it had on the patients.
The recall is impacts OriGen VV28F Reinforced Dual Lumen ECMO Catheters, which are single use cannulas allowing for the simultaneous drainage and re-infusion of blood through the internal jugular vein during life support procedures.
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The recalled catheters come from two separate lots: Lot N18487, catalog number VC28F with manufacture date August 14, 2014, and an expiration date of August 30, 2018; and lot N18487-1, catalog number V28F, with manufacture date April 15, 2015, and expiration date April 30, 2019.
Lot N18487 was distributed in the U.S. to users in Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Texas, Tennessee, Washington, and Wisconsin. Lot N18487 was also distributed to countries outside the United States, including Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, and Thailand.
Lot N18487-1 was distributed outside the U.S. to Chile, Colombia, India, Kingdom of Saudi Arabia, South Africa, and United Arab Emirates.
OriGen notified distributors and user facilities by email and is arranging for the return of all recalled products.
The FDA advises customers who received catheters from either of the affected lots they should return the products they currently have directly to OriGen.
The FDA also recommends users within the U.S. report adverse reactions or quality problems experienced with the catheters directly to the company and to the FDA’s MedWatch Adverse event reporting program online or by phone at 800-FDA-1088.
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