BIOSPHERE MEDICAL RECALLS HEPASPHERE MICROSPHERES

BioSphere Medical has instituted a voluntary recall of its HepaSphere Microspheres in Europe and Japan to correct a packaging defect that it identified while conducting aging studies routinely performed on all its product packaging.

HepaSphere Microspheres, which began shipping in late 2005, are contained in a prefilled vial that is packaged inside a paper pouch. The company determined that a defect in the paper pouch might compromise the sterility of the outside of the vial. If the sterility of the outside of the vial is not maintained, there is the risk that a physician's hands can become contaminated when handling the vial.

The company is not aware of any adverse events resulting from the defects in the paper packaging. Sales of HepaSphere Microspheres outside of the U.S. are expected to resume once a new packaging design is produced and validated.

"This is strictly a packaging issue, not a product performance issue," said Gary Saxton, BioSphere's executive vice president and COO. "We will correct the package defect as soon as possible to ensure that our HepaSphere Microspheres meet the highest standards of quality." ()a href="http://www.fdanews.com/ddl" target=_blank>