A New Jersey medical device company that manufactures pediatric heart valves, conduits and patches used in heart surgery is fighting the U. S. Food and Drug Administration in court, stating that the federal agency wrongly quarantined about 1 million of its product parts because of concerns over sterility and health risks.
According to an article last week in the New Jersey Star Ledger , Shelhigh suffered a setback on May 30 when a federal judge made a ruling refusing to release the devices seized by FDA in April. The judge stated that he would not determine whether those devices met safety standards without a hearing, which he said he will schedule soon.
Meanwhile, there is a virtual war of words going on between the federal officials and Shelhigh, which is a small company with 50 or so employees. Most of the company’s devices are exported to Europe, particularly Italy and Spain. According to this newspaper article, federal officials claim in court papers that Shelhigh used a poorly constructed and maintained clean room, and failed to properly test the sterility of products.
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