Urgent field safety notice for PTA dilatation catheter product families (Models Lutronix 014 and 035 OTW), Lutonix
2014.03.13
Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00684/14
Lutonix has issued an urgent field safety notice on drug coated PTA dilatation catheter product families (Models Lutronix 014 and 035 OTW). Some devices from specific lots may have been packaged in foil pouches with a defective seal. Lutonix is initiating a voluntary urgent device recall for such products.