CAPS initiated the ongoing recall July 14, according to an Aug. 1 report from the FDA. Among 27 solutions, 13,792 cardioplegia bags from the company’s Phoenix location were flagged for lacking decontamination validity.
In February 2022, an FDA inspection uncovered numerous quality and safety infractions at the facility, including a failure to check whether a batch has been distributed, a worker deleting assay testing data, reports missing calculations, and problems in airflow and sterilization. The agency called its safety and quality reporting “out of control.”
Hospitals are now in-sourcing compounded solutions of the drug, which is used to temporarily stop the heart during surgery.
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