Navigation Links
FDA Requests Recall of All Shelhigh Medical Devices

The U.S. Food and Drug Administration (FDA) today issued a formal written request to Shelhigh, Inc. to recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.

On April 17, 2007, U.S. Marshals, at FDA's request, seized all medical devices including components at Shelhigh's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but the company declined.

FDA recommends that doctors and hospitals consider using alternative products. Physicians and patients concerned about Shelhigh devices can visit www.fda.gov/cdrh/safety/041907-shelhigh.html and www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html for more information, including a list of the company's products.

"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, M.D., director, FDA's Center for Devices and Radiological Health. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."

The company's deficiencies, described in a complaint filed with the U.S. District Court of New Jersey, may compromise the safety and effectiveness of the devices. Shelhigh's own records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed.

Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, tube-like devices for blood flow (conduits), surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.


'"/>




Page: 1

Related medicine news :

1. Canadian Street Prostitutes Requests Protection
2. New Zealand Requests Details from Britain about ‘Black Sheep
3. Patients Requests for Antidepressants can Influence Physician Evaluation of Depression
4. Cyberkinetics Requests FDA to Sell Nerve Growth Stimulation System
5. FDA Requests Label Change for All Sleep Disorder Drug Products
6. A Batch Of Panadol Recalled
7. Boca Recalls Insulin Syringe Product Due To Contamination
8. Delhi Hospitals Cancel Holidays And Recalls Doctors
9. Azathioprine 50mg Pills Recalled By FDA And Roxane Labs
10. Antibiotic Drug Recalled Following Adverse Effects
11. Higher Lead Content Causes Recall of Toys
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: FDA Requests Recall All Shelhigh Medical Devices

(Date:3/2/2015)... ANTONIO (PRWEB) March 02, 2015 After ... quality processes, customer service, pricing and long-term strategy, Blood ... its vendor of choice for member centers’ testing needs. ... centers and represents more than 30 percent of the ... member meeting. , “BCA is committed to drive cost ...
(Date:3/2/2015)... New York (PRWEB) March 02, 2015 ... Recovery at Recovery Unplugged™—will be delivering a plenary ... Singer/Songwriter's Perspective on the Art of Healing and ... Disorders (NCAD) and Behavioral Healthcare Executive Summit (BHES).     ... name, Mr. Supa’s songs have been recorded by ...
(Date:3/2/2015)... Over the last five years the ultrasound ... to expand their geographic presence and achieve economies of ... $6.2 billion by 2019 at CAGR of 5.1% from ... and Canada and a major part of Europe are ... as Asia-Pacific including China and India, Latin America and ...
(Date:3/2/2015)... The minimally invasive surgical instruments market ... 6.1% to reach $14,133.0 million by 2019 from ... as advantages of minimally invasive surgeries over traditional ... invasive surgeries and increasing number of surgical procedures ... minimally invasive surgical instruments market. , For More ...
(Date:3/2/2015)... 2015 LegitScript, LLC, operator ... programs, including those for Internet pharmacy certification, ... and classification, has launched a certification program ... new program, called iCareRx , provides ... the identity of the owner/operator of Internet ...
Breaking Medicine News(10 mins):Health News:Blood Centers of America Chooses QualTex Laboratories as Vendor of Choice 2Health News:Blood Centers of America Chooses QualTex Laboratories as Vendor of Choice 3Health News:Richie Supa Announced as a Plenary Speaker at NCAD 2015 2Health News:Therapeutic Ultrasound Devices Market worth $6.2 Billion by 2019 - New Research Report by MarketsandMarkets 2Health News:Therapeutic Ultrasound Devices Market worth $6.2 Billion by 2019 - New Research Report by MarketsandMarkets 3Health News:Minimally Invasive Surgical Instrument Market - Global Forecast to 2019 - New Report by MarketsandMarkets 2Health News:LegitScript Launches Certification Program for Internet Eyeglass Sellers 2
... Pa., July 31 As tens of thousands of ... China, the,prospect of unexpected injury or illness -- and ... of many., "Finding adequate, appropriate medical care in ... their trip can give themselves,peace of mind," said Angelo ...
... (Nasdaq:,CYBX) today announced that the company will report financial results ... year ending April 24,2009 on Thursday, August 21, 2008 at ... discuss those results on the same day at 9:00 AM ... Instructions, To listen to the conference call live by ...
... Help plans attract, retain and manage consumers. , ... ... Connextions Inc. as a Marketing Applications vendor in its "Hype Cycle ... helps health insurance plans to attract, retain and manage individual ...
... Kenneth O.,Klepper, president & chief operating officer, Medco Health ... the BMO Capital Markets 2008 Focus on,Healthcare Conference in ... presentation at the Millennium Broadway Hotel will begin at ... also scheduled to,attend., The presentation may be heard ...
... When Kirk Manuel speaks,you hear anguish in his voice. You ... members of his community impacted by HIV and AIDS., When ... hear a,man who believes in his product, Head Strong Condoms, and ... a town in Arkansas, a town that has lost,several residents to ...
... new studies examine the use of the nucleoside polymerase ... The reports appear in the August issue of ... Sons on behalf of the American Association for the ... online at Wiley Interscience ( www.interscience.wiley.com ). , ...
Cached Medicine News:Health News:Americans Attending Beijing Olympics Should Plan Ahead for Medical Emergencies 2Health News:Cyberonics Announces Conference Call to Discuss Fiscal Year 2009 First Quarter Financial Results 2Health News:Connextions Cited in Leading Industry Analyst Firm's "Hype Cycle" For Health Care Provider Marketing Applications 2Health News:Connextions Cited in Leading Industry Analyst Firm's "Hype Cycle" For Health Care Provider Marketing Applications 3Health News:Medco to Present at the BMO Capital Markets 2008 Focus on Healthcare Conference 2Health News:African American-Owned Condom Company Fears the Widening AIDS Epidemic 2Health News:New treatment therapy helps inhibit hepatitis C 2
(Date:3/2/2015)... THOUSAND OAKS, Calif. , March 2, 2015 /PRNewswire/ ... that it will present 15 abstracts, including data evaluating ... Corlanor ® (ivabradine), an investigational drug for chronic ... 64 th Annual Scientific Session (ACC.15), being held ... Repatha is a fully human monoclonal antibody ...
(Date:3/2/2015)... , March 2, 2015  BC Technical, the ... has acquired Eclipse Systems, a Nuclear Imaging service ... As part of their ongoing vision to provide ... affordable rate, BC Technical continues to expand their ... Technical to add valuable resources and knowledge in ...
(Date:3/2/2015)... Click here for additional information on the ... DPLO ), the nation,s largest independent specialty pharmacy, announced ... 2014. All comparisons, unless otherwise noted, are to the quarter ... Quarter 2014 Highlights include: , Revenue of $612 ... of 208,000, an increase of 11% , Gross margin ...
Breaking Medicine Technology:Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 2Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 3Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 4Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 5Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 6Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 7Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 8Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 9Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 10Amgen Showcases Cardiovascular Pipeline At ACC.15 With New Cholesterol-Lowering And Chronic Heart Failure Data 11BC Technical Acquires Eclipse Systems 2Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 2Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 3Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 4Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 5Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 6Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 7Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 8Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 9Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 10Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 11Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 12Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 13Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 14Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 15Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 16Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 17Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 18Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 19Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 20Diplomat Announces 4th Quarter and 2014 Year End Financial Results; Provides Initial 2015 Guidance 21
... 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 ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... 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 ...
Medicine Products: