Product: CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Reason for recall: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Recall initiated: 20230817
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated