CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, tot...
FDA Recall #D-1038-2023 — Class II — July 14, 2023
Product Description
CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling Firm
Central Admixture Pharmacy Services, Inc. — Phoenix, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
184 bags
Distribution
Nationwide in the USA
Code Information
Lot: 36-251456, Exp. 7/14/2023; 36-256020, Exp. 7/28/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated