FDA (Devices) recall action 80199
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CryoLife, Inc. is recalling one unit of Cryopatch SG Pulmonary Human Cardiac Branch because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
CryoLife, Inc. is recalling one unit of the Cryovalve SG Pulmonary Human Heart Valve because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.