Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL...
FDA Recall #D-1112-2023 — Class II — August 17, 2023
Product Description
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
Reason for Recall
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
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
786 Bags
Distribution
Nationwide in the USA
Code Information
Lot# 36-260068, 36-260062, 36-260070, 36-260063, 36-260064, Exp 8/29/2023; 36-260016, Exp 9/3/2023; 36-262540, 36-262536, 36-262534, Exp 9/9/2023; 36-262990, 36-262992, Exp 9/12/2023. ;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated