Central Admixture Pharmacy Services, Inc. recalls Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL,
Recalled September 6, 2023 · FDA recall D-1112-2023 · Central Admixture Pharmacy Services
Hazard
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles · FDA Class II
Units
786 Bags
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Product
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
Manufacturer(s)
Central Admixture Pharmacy Services, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →