Terumo Cardiovascular Systems
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Terumo CVS' Consent Decree?
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About Terumo CVS' Consent Decree
Consent Decree Fact Sheet
- On March 22, 2011,Terumo Cardiovascular Systems (Terumo CVS) announced that it has agreed on the terms of a consent decree with the U.S. Food and Drug Administration (FDA) regarding improvements to the Quality System at the company’s Ann Arbor, Michigan plant. The decree went into effect on March 29, 2011.
- In the medical device industry, a consent decree is an agreement between the FDA and a device manufacturer that defines the terms under which the company can continue to conduct business while it addresses FDA’s concerns.
- The consent decree is in response to concerns raised by the FDA regarding the processes and procedures used by Terumo CVS to manufacture products at its Ann Arbor plant. The FDA noted its concerns during past inspections of the facility.
- The key terms of the consent decree are:
- Terumo CVS will develop a work plan to resolve deficiencies noted in an independent audit of its Quality System. Terumo CVS will submit the plan to the FDA for approval. Terumo CVS’ progress will be documented by an independent auditor on a regular basis. Terumo CVS’ goal is to complete all actions in the work plan within two years.
- Until Terumo CVS completes the actions in the plan, it agrees to restrict distribution of certain products built at its Ann Arbor plant to existing customers who deem the products medically necessary. Products manufactured at the plant include heart-lung machines and cannulae used in cardiac surgery. For a complete list of products subject to the restrictions, see Status of Terumo CVS’ Products.
- Terumo CVS agrees to pay the FDA a disgorgement of $35 million.
- All other Terumo CVS products are exempt from the consent decree and are available without restriction, including:
- Terumo CVS products manufactured at its other plants in Ashland, Massachusetts and Elkton, Maryland, including, but not limited to: oxygenators, perfusion circuits that do not contain Terumo cannulae, shunt sensors and cuvettes for CDI™ Monitoring Systems, Sarns™ Disposable Centrifugal Pump and others.
- Products manufactured by third parties, but distributed by Terumo CVS.
- Products manufactured by any other Terumo entity.
- For a complete list of products subject to the restrictions, see Status of Terumo CVS’ Products.
- The consent decree does NOT require Terumo CVS to remove, recall or perform any corrective actions on the products currently in clinical use (or in inventory) at customer facilities.