Princeton, NJ - The manufacturers of iopamidol (Isovue, Bracco Diagnostics) power-injector syringes have initiated a voluntary class 1 recall because of evidence of particulate matter in retained samples .
The US Food and Drug Administration (FDA) last week issued a safety alert on MedWatch, the FDA's safety information and adverse-event reporting program.
A total of nine lots were recalled. Although Bracco Diagnostics was contacted for comment, the company was unwilling to disclose how many units were subject to the recall and how many might still be circulating.
The prefilled, single-use power-injector syringes are designed to be used in combination with Stellant CT Injection Systems for the purposes of angiography throughout the cardiovascular system.
Products were distributed from January 21, 2010 through May 9, 2012 to wholesalers and distributors nationwide.
According to the manufacturer, no adverse events or customer complaints associated with these lots have been reported. However, the FDA points out that "the visible particles in the lots subject to this recall have the potential to cause adverse health consequences," including stroke.
The FDA states that products affected by the recall should not be used and should immediately be quarantined. Product can be returned to Stericycle, Bracco's contractor for handling the recall, at 1-866-201-9133. Call-center hours are Monday through Friday from 8 am to 5 pm Eastern Standard Time.
To report problems with the syringes, contact MedWatch by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online; with postage-paid FDA form 3500; or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Heartwire from Medscape © 2012
Cite this: Iopamidol contrast injector syringes recalled - Medscape - Dec 04, 2012.