Product: CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0101-1
Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recall initiated: 20230714
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated