News | March 22, 2011

Terumo Reaches Agreement on With FDA Regarding Factory Improvements

March 22, 2011 - Terumo Cardiovascular Systems (CVS) said it agreed to the terms of a consent decree with the U.S. Food and Drug Administration (FDA) regarding quality system improvements at the company's Ann Arbor, Mich., 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 concerns raised by FDA inspectors during audits of quality system processes at the Ann Arbor plant. Under the agreement, Terumo 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 do not contain cannulae, and all other products produced at the company's other manufacturing facilities in Elkton, Md., and Ashland, Mass.

The consent decree does not involve any other Terumo subsidiary or corporate entity.

Terumo 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 create systemic, sustainable improvements in its Quality Systems," said Mark Sutter, president and CEO, Terumo CVS. "Terumo CVS has always been, and will remain, committed to those in the cardiac surgery community who use our products. Our ultimate goal during the consent decree is minimizing the inconvenience or disruption to our customers."

For more information: www.terumo-cvs.com/consentdecree

Related Content

Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
Overlay Init