Terumo Cardiovascular Systems Reaches Agreement on Terms of Consent Decree With FDA Regarding Quality System Improvements
ANN ARBOR, Mich., March 22, 2011 /PRNewswire/ -- Terumo Cardiovascular Systems (Terumo CVS), a U.S.-based subsidiary of Terumo Corporation of Tokyo, Japan, today announced it has agreed to the terms of a consent decree with the U.S. Food & Drug Administration (FDA) regarding quality system improvements at the company's Ann Arbor, Michigan facility. The agreement will be subject to the approval of the United States District Court for the Eastern District of Michigan.
The consent decree addresses observations raised by FDA inspectors during audits of quality system processes at the company's Ann Arbor, Michigan plant. Under the agreement, Terumo CVS will create and execute a work plan to resolve the observations. Until the work plan is complete, Terumo CVS agrees to restrict the distribution of certain products manufactured at the plant to existing customers who deem the products medically necessary. Products manufactured at the plant include heart-lung machines and cannulae, and other related products used in cardiac surgery.
Other Terumo CVS products are available without restriction, including: oxygenators, perfusion circuits that don't contain cannulae, and all other products produced at the company's other manufacturing facilities in Elkton, Maryland and Ashland, Massachusetts; and products distributed by Terumo CVS that are manufactured by other suppliers.
The consent decree does not involve any other Terumo subsidiary or corporate entity.
Terumo CVS products are safe for use when used in accordance with their Instructions for Use. The consent decree does not require that the company remove, recall or perform corrective actions on any products in use at customer facilities.
"Terumo CVS is committed to fully addressing all of the FDA's concerns. Over the past year, Terumo CVS had already begun implementing a significant quality system initiative that will cre