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product_liability shelhigh-deviceOn May 2, 2007, the Food and Drug Administration formally requested the implantable medical device maker, Shelhigh Inc., to issue a recall of all products still on the market because of safety concerns , particularly regarding the sterility of the devices. In April, the agency, together with U.S. Marshals, seized all devices at the company's New Jersey manufacturing plant. At that time, the FDA asked Shelhigh to recall the remaining devices, but the company denied this request.
FDA officials warn that the safety and effectiveness of the devices may have been compromised as a result of poor manufacturing processes. Individuals who have suffered an adverse effect should make a report to the FDA and contact an attorney to learn more about holding Shelhigh responsible for any injuries or losses.
What You Should Know About the Shelhigh Recall
Prior to the Shelhigh recall, the company's deficient manufacturing processes had for years been the subject of FDA scrutiny. In 2000 and 2005, Shelhigh received warning letters, and after an inspection in 2006 revealed continued violations, the company's medical devices were seized .
Shelhigh medical devices are implanted into critically ill patients—infants, children, and adults—during various surgical procedures. The devices include pediatric heart valves, dural patches, arterial grafts, surgical patches, annuloplasty rings, and conduits that help blood flow. Devices that are not sterile could cause serious infection or other illness.
The FDA is urging doctors and hospitals to use alternative medical devices. Patients who experience health problems should consult with a physician immediately.
Shelhigh Lawsuit
Shelhigh has repeatedly refused to comply with FDA warnings and requests, putting patients at risk of serious injury. The company's failure to comply with the Shelhigh recall and other FDA requests shows a blatant disregard for patient health and safety, and those who have suffered injury because of a defective medical device may be able to hold Shelhigh responsible for their losses.
If you or someone you love has been injured by a Shelhigh device, you may be eligible to file a lawsuit to recover damages, including:
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An injunction entered yesterday in the U.S. District Court forbids the Union, N.J. company Shelhigh from distributing the medical devices it manufactures until the company's fac...