Bracco Isovue Pre-Filled Power Injector Syringes Recalled Due to Particulates

FDA announces Class I recall of iodine-based CT contrast agent

 

December 4, 2012

December 4, 2012 — Bracco Diagnostics Inc. is voluntarily initiating a Class I recall of nine lots of Isovue (iopamidol injection) pre-filled power injector syringes (Isovue PFS, to be used in combination with Stellant CT [computed tomography] injection systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples. These products were distributed to wholesalers and distributors nationwide.

Bracco has received no reports of adverse events or customer complaints associated with these lots. However, it should be noted that the visible particles in the lots subject to the recall have the potential to cause adverse health consequences. The dates for distribution of the nine affected lots were from Jan. 21, 2010 through May 9, 2012.

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 pre-filled syringe (PFS) presentations of Isovue — 300 FLS2 and Isovue — 370 FLS2.

Hospitals, emergency rooms, clinics, physician offices and other 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, to arrange for return of the product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the U.S. Food and Drug Administration's (FDA's) MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online at www.fda.gov/MedWatch/report.htm; or
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm329948.htm

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