August 23, 2002 |
CryoLife Inc.'s heart valves may carry a risk of infection for patients, so doctors should consider using other suppliers if possible, the Food and Drug Administration said. CryoLife's heart valves weren't part of a recall earlier this month the FDA ordered for some of the company's products earlier this month. CryoLife officials couldn't be reached for comment. CryoLife shares fell 29 cents to $3.68 on the NYSE.
August 20, 2002 |
CryoLife Inc., which processes human tissue for transplant, said it is under investigation by the Securities and Exchange Commission after a sweeping federal recall of the company's tissues last week. CryoLife, based in Atlanta, said the SEC has requested information on its accounting practices and trading in company shares in the last 11 months, a period in which health officials are investigating how the company handled tissue. Its shares, which were halted before the news, rose 6 cents to $3.
July 13, 2002 |
The family of a Minnesota man who died after a knee graft filed suit against the company that provided the tissue, claiming it came from an infected cadaver. Surgeons planted the cartilage Nov. 7 into the knee of Brian Lykins, 23. He died four days later. Health investigators found a deadly bacterium in his body and in the cadaver from which the cartilage was lifted. The lawsuit says tissue bank CryoLife Inc.
August 15, 2002 |
The government on Wednesday ordered a Georgia tissue bank whose products are linked to a death and serious infections to stop distributing its cadaver tissue, charging that CryoLife Inc. can't guarantee the grafts are free of fungus or bacteria. The unusually harsh action by the Food and Drug Administration comes after months of failed inspections and negotiations with the Kennesaw, Ga.
June 18, 2006 |
Don't worry, the doctor told Brian Lykins' parents while preparing to use cartilage from a cadaver to fix their son's knee. A million people a year have operations that use tissue from donated dead bodies. The nation's largest tissue bank had supplied this cartilage. It was disinfected and perfectly safe, he assured them. But four days after this routine, elective surgery, Lykins -- a healthy, 23-year-old student from Minnesota -- died of a raging infection.