Cardioplegia Solution recall: Sterility Concern
CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only…
Why was Cardioplegia Solution recalled?
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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:36-253949, Exp. 7/20/2023; 36-255411, Exp. 7/23/2023.
- Product
- CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 144 bags.
- Distribution
- Nationwide in the USA
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)