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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:
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Isovue – 370 |
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Description |
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Lot Number |
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Expiry Date |
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Isovue – 370 FLS2 |
10 X 75 mL Power Injector Syringes, Stellant |
9L40746 |
12/31/2012 |
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Isovue – 370 FLS2 |
10 X 100 mL Power Injector Syringes, Stellant |
0A43705 |
01/31/2013 |
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Isovue – 370 FLS2 |
10 X 100 mL Power Injector Syringes, Stellant |
0C57509 |
03/31/2013 |
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Isovue- 370 FLS2 |
10 X 125 mL Power Injector Syringes, Stellant |
9K37791 |
11/30/2012 |
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Isovue – 370 FLS2 |
10 X 125 mL Power Injector Syringes, Stellant |
0C57521 |
03/31/2013 |
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Isovue – 370 FLS2 |
10 X 125 mL Power Injector Syringes, Stellant |
0E62913 |
05/31/2013 |
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Isovue – 300 FLS2 |
10 X 100 mL Power Injector Syringes, Stellant |
9K34572 |
11/30/2012 |
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Isovue – 300 FLS2 |
10 X 100 mL Power Injector Syringes, Stellant |
0A43282 |
01/31/2013 |
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Isovue – 300 FLS2 |
10 X 100 mL Power Injector Syringes, Stellant |
0C56283 |
03/31/2013 |
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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/.
