Cardioplegia Solution Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a high-risk sterile injectable used in cardiac surgery. The hazard—lack of validation data for sanitization cycles—creates a theoretical risk of microbial contamination. No illnesses or injuries have been reported, making this a precautionary recall based on process validation failure rather than confirmed harm.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution del Nido Formula, a sterile injectable used during cardiac surgery. The recalled product consists of 786 bags with a total volume of 1,052.8 mL each, distributed nationwide. The product contains PLASMA-LYTE A, Mannitol, Sodium Bicarbonate, Potassium Chloride, Magnesium Sulfate, and Lidocaine in specified concentrations.
The recall was issued due to lack of assurance of sterility resulting from lack of validation data for sanitization cycles. The manufacturer's sterilization process validation was incomplete, creating a theoretical risk of microbial contamination.
The affected lots include: 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); and 36-262990, 36-262992 (Exp 9/12/2023). The product was distributed nationwide in the USA.
Healthcare facilities and providers in possession of affected lots should immediately discontinue use and contact their pharmacy and surgical teams. Patients who received this product during a cardiac procedure should consult their healthcare provider if they have concerns. Adverse events related to this recall can be reported to the FDA.
The recalled product
- 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 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…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 786
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 (15)
- 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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