Bracco Diagnostics has issued a voluntary recall of nine lots of Isovue (iopamidol injection) prefilled power injector syringes.
The class I recall of the lots of Isovue syringes (Isovue PFS) used in combination with Stellant CT injection systems is due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.
Bracco has received no reports of adverse events or customer complaints associated with these lots. However, the visible particles in the recalled lots have the potential to cause adverse health consequences, the company noted. Isovue is indicated for angiography throughout the cardiovascular system, and arterial injection of Isovue for cerebral angiography with particulate matter formation could cause stroke.
Isovue PFS is a single-use item, administered for diagnostic imaging under medical supervision. The product is packaged in single-dose prefilled syringe presentations of Isovue - 300 FLS2 and Isovue - 370 FLS2. The recalled lots include 9L40746, 0A43705, 0C57509, 9K37791, 0C57521, 0E62913, 9K34572, 0A43282, 0C56283.
These products were distributed to wholesalers and distributors nationwide. The dates for distribution of the affected lots were from January 21, 2010, through May 9, 2012. Bracco is notifying wholesalers, distributors, and customers by mail, and is arranging for return of all recalled product. Healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine product and contact Stericycle, Bracco's contractor for handling the recall, at 866-201-9133 to arrange for return of the product. Call center hours are Monday through Friday 8 a.m.-5 p.m. Eastern time.
