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CARDINAL HEALTH
Cardinal Health 200, LLC · Model PN40LMBY2 · UDI-DI 10887488366708
OHA
Prescription
4
510(k) clearances
112
Adverse events (10 deaths)
4
Recalls
2
Facilities
Description
ORTHO LAMINECTOMY, KIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-28 | Artivion, Inc | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| 2024-03-06 | Artivion, Inc | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. |
| 2020-11-10 | CryoLife, Inc. | 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 al |
| 2018-05-14 | CryoLife, Inc. | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.