Presence of Particulates Provokes Pre-filled Isovue® Syringe Recall

In short

Bracco Diagnostics Inc. (BDI) 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 Injection Systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.

While the company has received no reports of adverse events or customer complaints associated with these lots it is concerned that the visible particles in the affected lots have the potential to cause adverse health consequences, including stroke, given their cerebral angiographic function.

Background

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. The full recall details including listing of affected parts and lot numbers can be found here.

These products were distributed to wholesalers and distributors across the U.S. between January 21, 2010 and May 9, 2012.

BDI is notifying wholesalers, distributors and customers by mail and is arranging for return of all recalled product.

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, at 1-866-201-9133 to arrange for return of the product. Call center hours are Monday through Friday 8am-5pm Eastern Standard Time.

Source: Bracco Diagnostics, Inc., Business Wire