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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.
Product is not approved for use in the EU and should not have been distributed in the EU.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
Undeclared wheat on the label of Roasted pumpkin seeds with salt.
Undeclared Allergens (Milk): Mi Costenita BOCADIN wafer with chocolate contains undeclared milk allergens.
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Donor tissue was released prior to information received regarding a pericardial effusion.
Donor tissue was released prior to information received regarding a pericardial effusion.
Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
Records noted that the infant donor's mother had tested positive for Hepatitis B.
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
Records noted that the infant donor's mother had tested positive for Hepatitis B.
An incorrect lot number was entered in the production record for the solution in which this allograft was packaged.
CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD.
A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.