Human tissue products 'recalled' in US

A leading US medical firm has quietly recalled hundreds of human tissue products destined for transplants around the nation that were supplied by a North Carolina broker believed to have a tainted history.

The broker used an unsterile embalming room to carve up dissect corpses to procure tissue, a Raleigh funeral home director said.

The US Food and Drug Administration shut down the body broker on Friday, but refuses to say how many people may have received potentially risky tissue.

It is the second scandal in less than a year in the booming tissue transplant industry. Cadaver tissue is used in more than a million transplants each year in such routine operations as back surgery and knee repairs. While such donated tissue does tremendous good, it is also little regulated, a three-month Associated Press investigation found earlier this year.

Improperly-processed or poorly-tested tissue can lead to infections including hepatitis or Aids or even death. Last year a scandal unfolded around Biomedical Tissue Services, a New Jersey company accused of using stolen bodies and of shipping nearly 20,000 potentially tainted bodyparts.

Federal authorities kept the North Carolina episode quiet until late last Friday, when the FDA shut down Donor Referral Services of Raleigh, North Carolina. The FDA said the company, run by Philip Guyett, had “serious deficiencies” in its processing, donor screening and record-keeping. The government accused him of altering records to overlook such problems as cancer or drug use by the deceased donor.

But on July 6 the tissue provider, AlloSource of Centennial, Colorado, began its own recall of about 300 Guyett-provided transplant parts that went to a company it had acquired, an AlloSource spokeswoman said .

The FDA won’t say how many potentially tainted bodyparts might have made it to hospitals for transplant. But two companies doing business with Guyett told reporters that they know of at least 60 bodies cut up and at least 300 bodyparts that were recalled. And those firms were not the only business associates that Guyett had, they said.