Italy's Bracco Diagnostics disclosed this week that it is undertaking a Class I recall--the most serious--of 9 lots of its Isovue pre-filled power injector syringes because of visible particles inside them. Executives are worried that the tainted products could cause strokes.
Bracco is a fairly large operator in the medical imaging sector, and does business in 90 different global markets. Parent company Bracco Group is based in Milan, Italy, with manufacturing operations in Italy, Switzerland, Japan, China and Germany. No word yet on which manufacturing operations handled the affected lots.
The company cautioned that it hasn't received any reports yet that the products caused any patient injuries, but said it is pursuing the voluntary recall because of potential problems. Isovue is a single-use syringe, designed for medical imaging for an angiography. Officials have also informed the FDA about Bracco's recall effort.
Bracco's Isovue 300 FLS 2 and Isovue 370 FLS2 are affected by the recall, covering lots distributed between Jan. 21, 2010 and May 9, 2012, the company said.
Bracco is still in the process of informing retailers, wholesalers, distributors and customers about the action. The action includes plans to have the affected lots returned directly to the company. Executives contracted Stericycle to handle the recall effort itself, they explained. In the mean time, Bracco is urging hospitals, emergency rooms, clinics, physician offices and other customers to avoid the affected lots, effective immediately.
- here are more recall details