The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning VV13F Reinforced Dual Lumen ECMO Catheters, manufactured by OriGen Biomedical.
The manufacturer initiated a recall for one lot (lot N18549, expiration 09/2018) of 51 VV13F Reinforced Dual Lumen ECMO Catheters in the United States. These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage.
Affected users who have lot N18549 of VV13F Reinforced Dual Lumen ECMO Catheters should return any product that they currently have to OriGen Biomedical.
For details, please refer to the FDA website:
http://www.fda.gov/Safety/Recalls/ucm443009.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 April 2015