Navigation Links
FDA: Michigan Heart-Lung Bypass Machine Manufacturer Enters Into Consent Decree
Date:3/22/2011

SILVER SPRING, Md., March 22, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The consent decree, to be filed in the U.S. District Court for the Eastern District of Michigan by the Department of Justice, Office of Consumer Litigation, and the United States Attorney's Office, prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers.

The consent decree also restricts sale of these systems to existing customers until TCVS complies with the FDA's current Good Manufacturing Practice (cGMP) and Medical Device Reporting (MDR) requirements.

TCVS also agreed to pay the federal government $35 million in disgorgement of profits derived from past sales and additional disgorgement amounts should it fail to comply with the provisions of the consent decree in an effective and timely manner.

"Medical device manufacturers must comply with the FDA's current Good Manufacturing Practice and Medical Device Reporting requirements, as this action demonstrates," said Steven Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health. "These requirements protect patients by assuring that medical devices are safe, effective, and high quality."

During an inspection from January through March 2010, FDA investigators observed numerous cGMP and MDR violations at the company's Ann Arbor manufacturing facility. The violations included deficiencies in processes for corrective and preventiv
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Zell Lurie Institute Awards $106,300 to University of Michigan Students Through the Michigan Business Challenge and Dare to Dream Startup Grant Program
2. Michigan Pre-Seed Capital Fund Reports Investments Totaling $2.5 Million in 2010
3. SurgiCount Medical Announces the Successful Implementation of the Safety-Sponge® System at the University of Michigan Health System
4. Exciting Healthcare News for Women of Mid Michigan
5. Southeastern Michigan Gets First Ever FDA Approved Device That Destroys Fat Cells ... Without Surgery
6. Business Accelerator Network for Southeast Michigan Announces Accelerate Michigan Innovation Competition
7. Michigan Home Medical Providers Call on Congress to Preserve Homecare as an Option for Seniors and People With Disabilities Under Medicare
8. University of Michigan Wolverine Venture Fund Invests in Delphinus Medical Technologies
9. Karmanos Cancer Center Surgeon is Michigans First to Perform Transoral Robotic Surgery on Patients
10. Diabetics Twice as Likely to Have Hearing Loss; Michigan HearUSA Centers to Offer Free Hearing Screening and Diabetes Video in March
11. HearUSA Introduces AARP Hearing Care Program for Americans Aged 50-plus in Michigan Today
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... , Aug. 28, 2015 , ... Dr. Ra from Biostar , Published in ,Stem ... increase of lifespan through multiple IV administration of Adipose-derived ... and life expectancy found , Commercialization within 5 ... determined the possibility that adult mesenchymal stem cells (MSCs) ...
(Date:8/28/2015)... and LONDON , August 28, 2015 ... approach seamlessly connects people, technologies ... improving outcomes and the cost of ... PHG AEX: PHIA) today announced its presence at  ESC Congress ... solutions, including Heart Model A.I. , EchoNavigator and IntelliSpace Cardiovascular, ...
(Date:8/27/2015)... 27, 2015  A recent study by Feucht ... compared the Arthrosurface HemiCAP® Wave implant, which is ... "onlay" design implant for isolated patellofemoral disease. While ... and pain scores, none of the patients in ... However, 53% of the patients in the "onlay" ...
Breaking Medicine Technology:Korean Researchers Find the Possibility that Adult Mesenchymal Stem Cells (MSCs) May Extend Lifespan 2Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 2Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 3Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 4Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant 2Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant 3
(Date:8/29/2015)... ... August 29, 2015 , ... Vascular Health Sciences ... sell Arterosil and Arterosil HP, and that all claims and counterclaims have been ... Sciences, LLC (VHS) in the United States District Court for the Southern District ...
(Date:8/28/2015)... (PRWEB) , ... August 28, 2015 , ... An online ... decision to make the purchase of CPAP equipment more affordable by offering shipping at ... all types of CPAP products and orders of any size. My Cpap Store is ...
(Date:8/28/2015)... (PRWEB) , ... August 28, 2015 , ... An ... that local pizza maker Paul LaRocco has gone through to open a pizzeria in ... and permitting process tends to take several months, but the current process, having already ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... FDA’s Position and Best Practices for Compliance, **Presented by FDAnews and GessNet**, ... chaired by internationally renowned expert Fubin Wu, has been specifically designed to ...
(Date:8/28/2015)... ... August 28, 2015 , ... On May 30th, 2015, Best Drug Rehabilitation, ... the “Music With A Mission” benefit concert in Mendon, IL. Held in the Show ... money to support music education programs in the underfunded local school districts of Mendon ...
Breaking Medicine News(10 mins):Health News:My Cpap Store Now Offering Delivery Special 0 Cost to You 2Health News:Article on Building Approval Process for LA Business Highlights the Need for a Bridge Between Businesses and City Officials, says Fire Protection Group Inc. 2Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 2Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 3Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 4Health News:FDAnews Announces — Software and Cybersecurity Risk Management for Medical Devices: Understanding the FDA’s Position and Best Practices for Compliance, Oct. 14-15 5Health News:New Video Released on "Music With A Mission" Benefit Concert Headlining Artist Cadillac Three & Best Drug Rehabilitation 2
... Derek Griffiths, Ph.D., professor of geriatric medicine, University of Pittsburgh ... to the reduced activity of the orbitofrontal cortex of the ... recent issue of the Journal of Urology. He studied the ... , He analyzed the brain activity of 6 normal people ...
... has been an increase in the number of breast cancer ... reported to have been diagnosed with the ductal carcinoma// in ... in finding out which of the hormone therapy drugs are ... derived from both tamoxifen and anastrozole are being studied. The ...
... as the Plan Ahead kit comes down as a boon for ... about their pregnancy//. The kit is very simple and was ... It gives them a clear view about their biological cycle. ... standard levels. The results help the women to decide on the ...
... Medicine and Allergy, University Hospital, Sweden and his collaborators ... increased inflammation response in the lungs of the exposed ... pathways and openings and when they analyzed the inflammatory ... found a decreased inflammatory cells which they feel is ...
... Humans are known to damage. And a new study ... study points to a catastrophic collapse in orangutan populations// ... Sanctuary in Sabah, Malaysia. Benoit Goossens, Lounès Chikhi, ... the collapse occurred within the past hundred years. The ...
... can be used to clean the land which has been ... University of York. The team led by the University of ... bacterial micro- // organism in the soil in land contaminated ... of nitrogen for growth. ,However, on finding ...
Cached Medicine News:Health News:New fertility kit, analyzes the woman's ability to conceive 2
Blood pressure monitor will measure blood pressures and pulse rates accurately and reliably....
... Blood Glucose Monitoring System has the largest ... really easy to see and hold. FreeStyle ... the smallest sample of blood. And it's ... 5 seconds. With 4 programmable alarms, you'll ...
When you use the optional REAL-Time Continuous Glucose Monitoring Kit with your insulin pump, you will have access to REAL-Time glucose readings, safety alarms, and glucose trend data around the cloc...
... into testing wells and read results. ... multiple drug screen cassette that can ... adulterants. It can test from one ... can be accompanied with four (4) ...
Medicine Products: