The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning VV28F Reinforced Dual Lumen Extracorporeal membrane oxygenation (ECMO) Catheters [Catalogue number VV28F; Lot numbers: N18487 and N18487-1], manufactured by OriGen Biomedical.
The manufacturer initiated a recall for these two lots of VV28F Reinforced Dual Lumen ECMO Catheters.
The affected 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.
The manufacturer is aware of two product failures and has received two complaints associated with the problem. A recurrence of this event could result in serious patient injury.
The manufacturer is arranging for return of all recalled product.
For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575937.htm
https://www.fda.gov/Safety/Recalls/ucm575736.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 September 2017