FDA Seizes a Million Non-Sterile Medical Devices

Michael Phelan

Attorney
(866) 735-1102 Ext 375

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U.S. marshals and Food and Drug Administration investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about sterility. The seizure from Shelhigh Inc. was expected to net an estimated one million parts and finished products. The FDA said it had found significant problems in the Union, N.J., company's manufacturing processes. The federal officials seized all implantable medical devices from the company, saying the problems could compromise their safety and effectiveness, including the sterility of the implants. The products include pediatric heart valves and conduits, or tube-like devices for blood flow, as well as surgical patches, arterial grafts and annuloplasty rings.

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