Cardioplegia Solution del Nido Formula recall: Sterility Concern
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…
Why was Cardioplegia Solution del Nido Formula recalled?
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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. ;
- 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…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 786 Bags
- Distribution
- Nationwide in the USA
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)