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All product recalls associated with Cryolife Inc.
Total Recalls
70
Past Year
0
Class I (Serious)
1
Most Recent
Oct 2021
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
The heart valve procurement exceeded the warm ischemic time criteria.
Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
Microorganisms detected in associated allografts.
Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.
Microorganisms were detected in associated allografts after initial release of donor.
Microorganisms were detected in associated allografts.
CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.