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Shelhigh Seizure, 4.18.07

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FDA Seizure of Implantable Medical Devices from Shelhigh in New Jersey


April 18, 2007, New York, NY--After repeated warning letters and meetings with the company about its violations, the U.S. Food and Drug Administration raided Union, New Jersey-based Shelhigh, Inc. yesterday, seizing all implantable medical devices. The FDA said it found significant problems with the company’s manufacturing process, citing concerns about the sterility and effectiveness of its implants.

The products seized in the raid include pediatric heart valves and conduits, or the tube-like devices used for blood flow, surgical patches, arterial grafts and annuloplasty rings used to help repair heart valves. The FDA said those who are most vulnerable in using these devices are critically ill and pediatric patients, as well as people with compromised immune systems.

According to the FDA, Shelhigh’s numerous breaches include: failing to adequately monitor its manufacturing environments for possible mircrobial contamination; failing to properly test its products for sterility and fever-causing contaminants, and failing to scientifically support expiration dates. The seizure followed an FDA inspection of the company last fall; the agency also sent Shelhigh warning letters in 2000 and 2005.

FDA officials are recommending that physicians use alternative implant devices. Health workers are instructed to closely monitor patients with Shelhigh implants for infections and ensure that the devices function properly over the lifetime of the product. The agency is also urging patients who believe they may have received a Shelhigh implant during surgery to be in touch with their doctors. More information is available at the website www.fda.gov

If you were implanted with one of these devices and experienced an injury, our legal team may be able to assist you. Please complete the form below for a free legal review of your potential case. A representative of our firm will be in touch as soon as possible.

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Were you implanted with a medical device manufactured by Sheligh Inc?
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When were you implanted with this device?
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see also:

Shelhigh Patients FDA Notification to Patients about Contaminated Shelhigh Inc. Implants
FDA Warns Patients About Possible Contamination to Shelhigh Implants

Shelhigh Lawsuit Were You Injured by a Medical Device Made By Shelhigh? Lawsuit Info
Unsanitary Products From Shelhigh Facility in Union Spark Lawsuits

Shelhigh Inc. FDA Seizes all Medical Products From Shelhigh, Inc. Due to Violations
FDA Raid After Repeated Violations from Shelhigh Medical Devices in NJ

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