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:10/20/2014)... , Oct. 20, 2014 Lpath, Inc. ... in bioactive lipid-targeted therapeutics, received official notification from the ... granted another key patent supporting its iSONEP™ and ... patent, European patent No. 2087002, claims compositions of ... Lpath,s two lead compounds, iSONEP and ASONEP. Sonepcizumab ...
(Date:10/20/2014)... Norgine B.V. today announced that the Phase ... NER1006, presented at the 79 th Annual Scientific ... Philadelphia, PA , has met its primary ... of cleansing success. The study demonstrated high quality bowel ... screening colonoscopy patients. [1] (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a) ...
(Date:10/19/2014)... CTI BioPharma Corp. (CTI) (NASDAQ and MTA: ... quarter 2014 financial results on Wednesday, October 29, 2014, ... the announcement, members of the management team will host ... provide a general corporate update at 4:30 p.m. EDT ... obtained as follows: Wednesday, October 29 ...
Breaking Medicine Technology:Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 2Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 3Lpath Granted Key European Patent Related to iSONEP and ASONEP Programs 4Positive Results from Phase II Data Show NER1006 Achieves High Quality Bowel Cleansing Efficacy 2CTI BioPharma to Report Third Quarter 2014 Financial Results on October 29, 2014 2
... April 12, 2011 Visual Healthcare Corp. (the "Company") (NASDAQ ... Chinese based adaptation of the information technology grid that its ... This project has been launched in response to requests from ... experts responding to Chinese government resolve to create a major ...
... 2011 Southern Home Medical Equipment, Inc. (PINKSHEETS: ... professionals and equipment to medical institutions, announced today ... for fiscal year 2010 have been restated to ... Staffing. In a previous announcement dated ...
Cached Medicine Technology:Visual Healthcare to Support Chinese Clinical Trials 2Visual Healthcare to Support Chinese Clinical Trials 3Southern Home Medical Equipment Reports Additional Revenues and Profits for 2010 2
(Date:10/20/2014)... October 20, 2014 Houston plastic surgeon ... the key elements of his innovative True Form ... plastic surgery residents and faculty at The University ... he, too, was once a medical student. Patronella, who ... private cosmetic plastic surgery practices in Texas, The ...
(Date:10/19/2014)... Hastings and Hastings, a Phoenix personal injury law ... greater Phoenix area and across Arizona reports record demand ... automobile accidents. Statistics have indicated a steady increase in ... such, Hastings and Hastings has seen a steady increase ... have been injured through no fault of their own ...
(Date:10/19/2014)... 2014 Recently, BambooIndustry.com, one of the ... new range of bamboo deckings . Moreover, the ... items; they are now available at deeply discounted rates. ... is hard to overstate the significance of online business ... online services. The company’s workers are striving to deliver ...
(Date:10/19/2014)... Texas (PRWEB) October 20, 2014 ... development for Partial Seizure, complete with comparative analysis ... mechanism of action (MoA), route of administration (RoA) ... featured news and press releases. It also reviews ... Partial Seizure and special features on late-stage and ...
(Date:10/19/2014)... 20, 2014 Recently, Top10BestSEOHosting.com has ... that JustHost, GoDaddy and HostMonster are the best ... (Virtual Private Server) is the method of partitioning ... of which has the appearance and capabilities of ... why the site pays close attention to VPS ...
Breaking Medicine News(10 mins):Health News:Plastic Surgeon Patronella Presents Artistically-Inspired Tummy Tuck Method to Future Generation of Plastic Surgeons in Texas 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 3Health News:High Quality Bamboo Deckings, New Items Unveiled By BambooIndustry.com 2Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 2Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 3Health News:Partial Seizure Therapeutic Pipeline Market Review H2 2014 in a New Report Available at RnRMarketResearch.com 4Health News:The Best VPS Hosting Suppliers In The Market Unveiled By Top10BestSEOHosting.com 2
... 12 The Ensign Group, Inc. (Nasdaq: ... Ensign(TM) group of skilled nursing, rehabilitative care services ... of Suzanne D. Snapper to succeed soon-to-be-retiring CFO ... , Ms. Snapper has been serving as ...
... MedApps, Enabling Mobile Wireless Technology Links Patients, Care ... Retail Off-the-Shelf Medical DevicesSCOTTSDALE, Ariz., May 12 ... provide a new, convenient and cost effective solution ... health record. MedApps, HealthPAL is a unique solution ...
... Carbon Footprint at DaVita,s Six Corporate Business OfficesEL SEGUNDO, ... DVA ), a leading provider of kidney care services ... announced that the company is the first FORTUNE 500 ... (EPA) Green Power Partnership program. Joining this program is ...
... 12 Occlutech, the leading European,developer of septum occluders, today ... generation ASD and PFO occluders, the Figulla Flex. , ... encompass a new innovative,delivery system, making the use of a ... the ability of the delivery,system to allow a 45 degree ...
... will present technology and admissions educational sessions for ACHCA members ... ... 12, 2009 --Patient Placement Systems, the leading provider of automated ... will exhibit and present two sessions at the American College ...
... love its usability & CCHIT recognizes its functionality; CureMD EHR ... ... New York, NY (PRWEB) May 12, 2009 -- The Certification ... EHR v10 complies with updated interoperability requirements, is a conditionally ...
Cached Medicine News:Health News:The Ensign Group Announces the Retirement of CFO Alan J. Norman; Names Suzanne D. Snapper as New Chief Financial Officer 2Health News:MedApps HealthPAL Connects to Microsoft HealthVault to Improve Patient Compliance and Lower Healthcare Costs 2Health News:MedApps HealthPAL Connects to Microsoft HealthVault to Improve Patient Compliance and Lower Healthcare Costs 3Health News:DaVita Becomes the First FORTUNE 500 Healthcare Services Company to Join the EPA Green Power Partnership 2Health News:DaVita Becomes the First FORTUNE 500 Healthcare Services Company to Join the EPA Green Power Partnership 3Health News:Patient Placement Systems Presenting Two Sessions at ACHCA 2009 Convocation 2Health News:Patient Placement Systems Presenting Two Sessions at ACHCA 2009 Convocation 3Health News:Doctors Love its Usability & CCHIT Recognizes its Functionality; CureMD EHR v10 CCHIT 08 Certified 2Health News:Doctors Love its Usability & CCHIT Recognizes its Functionality; CureMD EHR v10 CCHIT 08 Certified 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: