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The CryoLife recall order was an unusually strong move, but according
to the director of the division of case management in the FDA's
Office of Compliance and Biologics Quality, Dr. Mary Markley, the
agency found "significant violations from our regulations."
CryoLife is the nation's largest supplier of heart valves obtained
from human donors and processes 70% of the nation's heart valves
and 90% of vascular tissue. Patients who have received CryoLife
soft tissue or heart valve implants should consult their physicians
and contact a Cryolife soft tissue recall lawyer for more information.
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