Covidien plc (NYSE:COV) announced a double-dose of regulatory wins for its Parietex Optimized Composite (PCOx) mesh, which received both 510(k) clearance from the U.S. Food & Drug Administration and CE Mark approval for the European Union.
Covidien launched PCOx during the recent European Hernia Society meeting in Ghent, Belgium, and the product will be commercially available in the U.S. and Europe starting in June.
Johnson & Johnson (NYSE:JNJ) is recalling nearly 400,000 insulin cartridges made by its Animas subsidary because of the risk that they might leak insulin.
Animas sent out a letter to patients Feb. 24 detailing the recall, saying "some of the 2.0 mL insulin cartridges shipped between Nov. 30, 2010 and Jan. 4, 2011, can leak insulin, resulting in the delivery of less insulin than intended. In addition, if the cartridge has a leak, the pump may not alarm if there is an occlusion in the infusion set," according to the letter.