Bracco Diagnostics (BDI) has recalled nine lots of Isovue PFS injector syringes, to be used in combination with stellant CT injection systems due to the presence of visible particles in syringes in the US.
The particles were observed at the end of standard stability studies on retained samples.
BDI has not received any customer complaints or adverse events associated with these lots.
Isovue is used for angiography throughout the cardiovascular system and arterial injection of Isovue with particulates is expected to cause stroke.
Isovue PFS is a single use product, administered for diagnostic imaging under medical supervision.
The product has been packaged in single dose prefilled syringe presentations of Isovue- 300 FLS2 and Isovue - 370 FLS2.
BDI has initiated the recall by intimating the US Food and Drug Administration.
