Alerta De Seguridad para vv28f reinforced dual lumen ecmo catheters

Safety alert

2017-09-14

2017-09-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170914.html

Medical device safety alert: origen biomedical vv28f reinforced dual lumen ecmo catheters 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.