Product: del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-984-10
Reason for recall: Lack of Assurance of Sterility; bags have potential to leak
Recall initiated: 20191009
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated