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:


(Date:8/19/2017)... ... August 19, 2017 , ... Parker at Stonegate, an assisted ... passionate employees, caregivers, volunteers, thought leaders, researchers, educators and partners leading the way ... time to refresh the carpeting with the goal of maintaining the same precise ...
(Date:8/18/2017)... , ... August 18, 2017 , ... More than 20,000 ... Republic of Congo (DRC) thanks to an ambitious venture that conjoined the passions of ... the generous support of the Liberty community. These shoes will save lives from the ...
(Date:8/18/2017)... ... August 18, 2017 , ... August 18, 2017 — Mediaplanet ... for active, healthy lifestyles and highlighting the importance of proactive eye and ear ... and shares the latest innovations in hearing aid technology. , According to ...
(Date:8/18/2017)... McLean, VA (PRWEB) , ... August 18, 2017 ... ... offers asset protection services and financial consultations to communities throughout the greater DC ... Semper K9 with the goal of rescuing local animals and training them to ...
(Date:8/18/2017)... ... August 18, 2017 , ... The Brian Gifford Agency, ... Indiana, is campaigning in support of Campagna Academy in a charity drive to provide ... “Hoosier Boys’ Town of Indiana,” Campagna Academy is a nonprofit organization that has offered ...
Breaking Medicine News(10 mins):
(Date:8/17/2017)... 2017 MJAC2017 , the premier cannabis event ... today reveals its leading lineup. MJAC2017 ... cannabis innovator specializing in the development of pharmaceutical and consumer ... Rambridge™ and The Green Organic Dutchman are gold sponsors for ... silver sponsors. ...
(Date:8/15/2017)... , Aug. 15, 2017   Mostyn Law and Gulf ... Houston, Texas . The Mostyn Law family ... 2 years. That is why Mostyn Law is partnering ... to show its appreciation. Blood supplies are running ... 5% short of hospital needs in August. That is why the ...
(Date:8/15/2017)... , Aug. 15, 2017 AccuGenomics, Inc., a ... , today announced that the company has provided an ... of North Carolina at Chapel Hill and to Qura ... to characterize and quantify HIV reservoir and viral expression ... intervention. The HIV Cure Center is a joint initiative ...
Breaking Medicine Technology: