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FDA Seeks Recall of Troubled Firm's Devices

Article-FDA Seeks Recall of Troubled Firm's Devices

FDA has taken the rare step of formally asking a device company for a recall. The agency wants Shelhigh Inc. (Union, NJ), whose headquarters it raided two weeks ago, to recall its devices from hospitals, reports the Star-Ledger of Newark, NJ. The agency raided Shelhigh because it decreed that the company did not fix problems stemming from two warning letters, particularly concerning sterility. The formal request comes after the agency had made an informal request that was rebuffed.

Such a rebuff is also rare: Most device companies voluntarily recall products when a serious problem is discovered, and almost all do it when FDA suggests it. If the formal request is not heeded, FDA can seek a court order mandating the recall. Given that what's in play are high-risk tissue-based devices such as heart valves, it would not be surprising at all if FDA took this to court. Yet, for now, Shelhigh remains defiant. Its marketing director says FDA has not presented any data to justify its recall request. So this is not the end of the story. Don't be surprised if Shelhigh hires Larry Pilot, if it hasn't already.

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