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
More like this
- FDA Grants 510(k) Approval for Several New or Improved Devices
- Terumo Recalls, Discontinues Coronary Ostia Cannula Line
- VirtuoSaph Plus Endoscopic Vessel Harvesting System from Terumo Provides Cardiac Surgery Team with Control, Consistency and Confidence
- Bariatric Surgical Instruments Offer Improved Reach
- FDA, Industry Reach Agreement on Medical Device User Fees