Devices Seized Amid Sterility Concerns
WASHINGTON (AP) -- U.S. marshals and FDA investigators on Tuesday began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about their sterility.
The seizure from Shelhigh Inc. was expected to net an estimated 1 million parts and finished products, said Food and Drug Administration spokeswoman Heidi Rebello. The FDA said it had found significant problems in the Union, N.J., company's manufacturing processes.