Central Admixture Pharmacy Services, Inc. recalls Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-L
Recalled August 9, 2023 · FDA recall D-0956-2023 · Central Admixture Pharmacy Services
Hazard
Lack of assurance of sterility. Validation data for decontamination cycles is lacking. · FDA Class II
Units
10,480 bags
Sold at
Nationwide in the USA
Description
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Product
Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, 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, Approx. Osmolarity 386 mOsm/L, 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 →