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Shelhigh Recall Articles

Medical Device Manufacturer Fights FDA Over Defective Product Recall

A New Jersey-based company that makes tissue-based products used in open-heart surgeries is embroiled in a heated court battle and war of words with the Food and Drug Administration (FDA). This tension between Shelhigh and the FDA began April 17 when the federal regulatory agency pulled about 1 million parts at the company's plant in New Jersey after a 10-week inspection of the facility in the fall of 2006.

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SHELHIGH MEDICAL DEVICE MANUFACTURER-UNDER THE GUN-FDA CLAIMS OF REPEATED PROBLEMS WITH CONTAMINATION SPUR 'RECALL'

Many of us remember the TV Shows The Six Million Dollar Man and The Bionic Woman, but most of us had no idea how close we would come to rebuilding our human bodies in the 21st century. Inventions and advances in medical technology have given so many a 'second chance' at life.

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