Nine lots of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant® CT Injection Systems) are subject to a Class I recall due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples. The visible particles in the lots subject to this recall have the potential to cause adverse health consequences. Isovue is indicated for angiography throughout the cardiovascular system. Arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke.
This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose Prefilled Syringe (PFS) presentations of Isovue® - 300 FLS2 and Isovue® - 370 FLS2.
These products were distributed to wholesalers and distributors nationwide. The dates for distribution of the nine affected lots were from January 21, 2010, through May 9, 2012. Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine the product.
See the Recall