Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Navilyst Medical Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits

22 Mar 2016

Medical device manufacturer, Navilyst Medical, Inc., has issued a medical device safety alert concerning Vaxcel PICC with PASV Valve Technology / Kits, Xcela PICC Triple Lumen with PASV Valve Technology Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits.

The manufacturer is recalling PICC that contained valve(s) manufactured prior to 15 July 2014. Valves manufactured after this date incorporate a manufacturing specification change that reduced the incidence of haemolysis during blood sampling through the PICC. According to the manufacturer, use of the affected products may result in an increased incidence of haemolyzed blood samples which may require additional peripheral access or replacement of the PICC.

According to the local supplier, only Vaxcel PICC with PASV Valve Technology / Kits are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 22 March 2016

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