Bracco Diagnostics issued a voluntary Class I recall of nine lots of Isovue (iopamidol injection) pre-filled power injector syringes (Isovue PFS, used in combination with Stellant CT injection systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.

Isovue is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging.

An arterial injection of Isovue with particulate matter formation could cause stroke in patients.  The affected lots of Isovue-300 FLS2 and Isovue-370 FLS2 include the following:

Isovue – 370

 

 

 

 

 

 

 

 

 

Description

 

 

 

 

Lot Number

 

 

 

 

Expiry Date

Isovue – 370 FLS2

10 X 75 mL Power Injector Syringes, Stellant

9L40746

12/31/2012

Isovue – 370 FLS2

10 X 100 mL Power Injector Syringes, Stellant

0A43705

01/31/2013

Isovue – 370 FLS2

10 X 100 mL Power Injector Syringes, Stellant

0C57509

03/31/2013

Isovue- 370 FLS2

10 X 125 mL Power Injector Syringes, Stellant

9K37791

11/30/2012

Isovue – 370 FLS2

10 X 125 mL Power Injector Syringes, Stellant

0C57521

03/31/2013

Isovue – 370 FLS2

10 X 125 mL Power Injector Syringes, Stellant

0E62913

05/31/2013


Isovue – 300

 

 

 

 

 

 

 

 

 


Description

 

 

 

 


Lot Number

 

 

 

 


Expiry Date

Isovue 300 FLS2

10 X 100 mL Power Injector Syringes, Stellant

9K34572

11/30/2012

Isovue – 300 FLS2

10 X 100 mL Power Injector Syringes, Stellant

0A43282

01/31/2013

Isovue – 300 FLS2

10 X 100 mL Power Injector Syringes, Stellant

0C56283

03/31/2013

Healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine products and contact Stericycle at (866) 201-9133.

For more information call (800) 631-5245 or visit www.braccoimaging.com/.