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-SpongeĀ® 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:1/14/2014)... , Jan. 14, 2014  Luminex Corporation (Nasdaq: LMNX ... the fourth quarter of 2013 on Monday, February 3, 2014. ... after the close of trading. (Logo: ... to discuss the operating highlights and financial results for the ...
(Date:1/14/2014)... 2014 Dynamic Healthcare Services, Inc. ("DHS"), a portfolio company ... Progressive Home Medical Equipment, Inc. ("Progressive") of Clarion, ... the acquisition were not disclosed. Progressive is ... wide range of sleep, mobility, and respiratory products to customers ...
(Date:1/14/2014)... PLYMOUTH, Minn. , Jan. 14, 2014   NuAire , a ... come to agreement with Hitachi Koki of ... centrifuges in North America . NuAire will utilize ... and Canada to offer assistance ...
Breaking Medicine Technology:Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 2Luminex Corporation Fourth Quarter Earnings Release Scheduled for February 3, 2014 3Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3NuAire announces sales and service of Hitachi Koki centrifuges in North America 2
... Be Presented --, SAN FRANCISCO, April 24, 2007 /PRNewswire-FirstCall/ ... Phase,2 efficacy study of Dimebon(TM) in Alzheimer's disease will ... at the American,Academy of Neurology's 59th Annual Meeting in ... The presentation will include new,data from both the mild ...
... WIRE)--Apr 24, 2007 - Ceragenix Pharmaceuticals,Inc. (OTCBB:CGXP) ... study comparing EpiCeram's(TM) efficacy to,that of Cutivate(R) ... of moderate-to-severe atopic dermatitis (AD)., The study, ... of 113,pediatric patients, with 59 patients receiving ...
Cached Medicine Technology:Medivation Announces First U.S. Presentation of Data From Dimebon,Phase 2 Alzheimer's Disease Trial at American Academy of Neurology,Annual Meeting 2Medivation Announces First U.S. Presentation of Data From Dimebon,Phase 2 Alzheimer's Disease Trial at American Academy of Neurology,Annual Meeting 3Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints 2Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints 3Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints 4Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints 5Ceragenix Announces Results from Phase IV Study of EpiCeram Meet,All Primary and Secondary Endpoints 6
(Date:4/23/2014)... from Sub-Saharan Africa, Latin America and Caribbean islands ... new research from St. Michael,s Hospital. , The ... of Obstetrics and Gynaecology , assessed the differences ... native-born women in six high-immigration countries Australia ... Valencia) and the United States (California, New Jersey ...
(Date:4/23/2014)... director at the National Institute of Arthritis and Musculoskeletal ... recipient of the Ross Prize in Molecular Medicine, conferred ... Medicine . The award will be given on June ... Manhattan, followed by scientific presentations by Dr. O,Shea and ... Institutes of Health. , The award, which includes a ...
(Date:4/23/2014)... report that rats exposed to high-energy particles, simulating conditions ... show lapses in attention and slower reaction times, even ... ranges. , The cognitive impairments which affected a ... appear to be linked to protein changes in ... to hold true in humans, suggest it may be ...
(Date:4/23/2014)... N.Y. A novel compound that targets an important ... of cocaine addiction behaviors, including relapse behavior, a University ... provides strong evidence that this may be a novel ... effective medications exist., The UB research was published as ... week. , In the study, the compound, RO5263397, severely ...
(Date:4/23/2014)... new computer program could help doctors predict which patients ... treatment. , The program, which assesses brain scans ... airport security and passport control, has been developed by ... study funded by the Wellcome Trust, which used the ... . , Stroke affects over 15 million people ...
Breaking Medicine News(10 mins):Health News:Pregnancy complications may be more common in immigrants from certain regions 2Health News:NIH scientist to receive Ross Prize in Molecular Medicine 2Health News:Some astronauts at risk for cognitive impairment, animal studies suggest 2Health News:Some astronauts at risk for cognitive impairment, animal studies suggest 3Health News:Novel compound halts cocaine addiction and relapse behaviors 2Health News:Airport security-style technology could help doctors decide on stroke treatment 2Health News:Airport security-style technology could help doctors decide on stroke treatment 3
... ... every year, 35 to 50 million Americans become infected with the flu (influenza). On average, ... Plano, TX is taking steps to combat these preventable deaths by offering free flu shots ... Plano, TX (Vocus) September 12, ...
... , , , ... important safety notice to its more than 750,000 subscribers of its ... wearing a "pendant" style help button. The service is used primarily ... at risk of falls. By pressing a "help button" worn on ...
... of Public Health has been awarded $18.4 million by ... U.S. Department of Defense to establish an Extremity Trauma ... the coordinating center for the Consortium that includes a ... with several major military treatment centers and the U.S. ...
... ... on the Failed War on Drugs , ... Las Vegas, NV (PRWEB) September 11, 2009 -- PAINWeek® 2009, the national conference ... drug reform in the United States as keynote speaker former Assistant US Attorney Jennifer Bolen, ...
... help predict who,s susceptible to the disease, study says , ... to a higher risk of Alzheimer,s disease seems to affect ... thought, new research suggests. , The brains of people in ... -- which boosts the risk of Alzheimer,s but doesn,t guarantee ...
... , NEW YORK, Sept. 11 Duane Reade Holdings ... that, as the Local Presenting Sponsor of the 2009 Komen New ... its foundation, The Duane Reade Charitable Foundation, have raised $330,000 to ... to find a cure. This marks the third year that Duane ...
Cached Medicine News:Health News:H1N1 frenzy may allow regular flu to be more deadly than ever 2Health News:Lifeline Issues Safety Notice to Subscribers 2Health News:JHSPH to lead extremity trauma clinical research consortium 2Health News:JHSPH to lead extremity trauma clinical research consortium 3Health News:Healthcare Legal Issues Take the Stage at PAINWeek 2009 2Health News:Healthcare Legal Issues Take the Stage at PAINWeek 2009 3Health News:Alzheimer's Gene Affects Brains of Young Adults 2Health News:New Yorkers Help Duane Reade Increase Support of the 19th Annual Komen New York City Race For The Cure(R) 2Health News:New Yorkers Help Duane Reade Increase Support of the 19th Annual Komen New York City Race For The Cure(R) 3
... of Hemoglobin S in patient samples. Each ... and 20l of anticoagulated whole blood or ... test kit contains two bottles of phosphate ... and two vials of Sodium Hydrosulfite reagent ...
... CD-Chex Plus BC is an assayed control ... systems. CD-Chex Plus BC determines the accuracy ... in the process of immunophenotyping, including red ... subsets of leukocytes include: T lymphocytes, B ...
Streck-T-Pack is specially designed for use on Coulter® Counter T Series instruments. Each convenient pack includes diluent, lysing agent and enzymatic cleanser. The shelf life is 18 months from ...
... CD-Chex CD34 is a ... leukocytes which can be used ... when evaluating CD34 positive cells. ... ISHAGE and ProCOUNT gating strategies. ...
Medicine Products: