Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits 의 안전성 경고

Safety alert

2015-01-07

2015-01-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150107.html

Medical device safety alert: navilyst medical xcela peripherally inserted central catheter (picc) with pressure-activated safety valve (pasv) valve technology / kits and bioflo picc with endexo and pasv valve technology / kits medical device manufacturer, navilyst medical, inc., has issued a medical device recall concerning xcela peripherally inserted central catheter (picc) with pressure-activated safety valve (pasv) valve technology / kits and bioflo picc with endexo and pasv valve technology / kits. the manufacture is recalling picc that contain valve(s) manufactured prior to 9 october 2013. valves manufactured after this date incorporate a manufacturing specification change that reduces the incidence of haemolysis during blood sampling through the picc. according to the manufacturer, use of the affected products may have an increased incidence of haemolyzed blood samples which may require additional peripheral access or replacement of the picc. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 january 2015.