Cardioplegia Solution recall: Sterility Concern
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc.…
Why was Cardioplegia Solution 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# 36-262315, Exp 8/21/2023; 36-262514, Exp 8/25/2023; 36-262993, Exp 8/28/2023.
- Product
- CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc.…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 304 bags
- Distribution
- Nationwide in the USA
- Recall date
- September 6, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)