Medtronic Recalls Disposable Heparin-Coated Device Line
This article was originally published in PharmAsia News
Medtronic announced it is recalling its disposable devices coated with Carmeda BioActive surface because they include heparin. The firm said it was exercising precaution in the wake of U.S. FDA advice based on an investigation of contaminated Chinese-produced heparin. Medtronic said it had no reports of problems with its Carmeda products, but it could rely on a separate line of disposable bypass-surgery products covered with trillium because they contain smaller amounts of heparin. (Click here for more
You may also be interested in...
A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.
The US HHS played defense on 20 September, pushing back on suggestions that secretary Alex Azar’s recent move to exert control over regulations by signing off on them was a power play aimed at the FDA. Meanwhile, former agency head Scott Gottlieb says it’s “the wrong move at the wrong time.”
With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?