Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 196 bags of cardioplegia solution nationwide due to lack of sterility assurance and missing validation data for decontamination cycles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II drug recall with no reported illnesses or injuries. The hazard—lack of sterility assurance due to missing validation data—is theoretical rather than confirmed contamination. However, cardioplegia solution is a critical-use product administered during cardiac surgery where contamination poses significant risk, meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 196 bags of Cardioplegia Solution (60 mEq K, Induction 4:1, High Potassium) nationwide. The affected product was distributed across the United States with lot numbers 36-251685 (expiration 7/15/2023) and 36-252364 (expiration 7/17/2023).
The recall is due to lack of assurance of sterility. The manufacturer lacked validation data for decontamination cycles, which is necessary to ensure the product meets sterility standards.
Cardioplegia solution is administered intravenously during cardiac surgery to protect the heart during the procedure. Contamination of this product could introduce harmful microorganisms directly into the surgical site.
Healthcare providers and hospitals who have received this product should stop using it immediately and contact Central Admixture Pharmacy Services or the FDA with any questions or to report adverse events.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 830 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: 36-251685
- Exp. 7/15/2023
- 36-252364
- 7/17/2023
Distribution
Distributed nationwide across the United States.
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