Product: CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1
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