Terumo Cardiovascular Systems Corp. has signed a consent decree prohibiting it from distributing two heart-lung bypass systems and other cardiovascular devices to new customers, the Food and Drug Administration announced March 22. The decree also restricts sale of the systems to existing customers until the company complies with the FDA’s good manufacturing practice and medical device reporting requirements.
Because of concerns about possible shortages, FDA said the company can continue to provide service, replacement parts and loaner devices to existing customers that submit documentation of medical need. Customers should receive a notification guide from the company with instructions for completing and returning a certificate of medical necessity.
[ via AHA News Now ]