Cardioplegia Solution del Nido Formula Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 10,480 bags of Cardioplegia Solution del Nido Formula nationwide due to missing validation data for decontamination cycles, creating potential sterility assurance risks.
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 sterile product for critical cardiac use (intracardiac perfusion during surgery). Although no illnesses have been reported, lack of sterility assurance in such a critical application represents a risk-of-harm product that meets the High severity criterion.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 10,480 bags of Cardioplegia Solution del Nido Formula, a sterile solution used during cardiac surgery for intracardiac perfusion. The recall affects product distributed nationwide in the United States.
The manufacturer determined that validation data for decontamination cycles is lacking, which means the manufacturer cannot provide assurance that the product has been properly sterilized. This creates a potential contamination risk for a product that must be sterile for safe use.
The affected product includes multiple lot numbers with expiration dates from July through August 2023. Healthcare facilities should identify and quarantine affected inventory using the specific lot numbers listed in the recall notice.
The recalled product
- Product
- Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, 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…
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Affected units
- 10,480
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 (20)
- Lot: 36-252365
- 36-252368
- 36-252369
- 36-253887
- 36-253888
- Exp. 8/1/2023
- 36-254404
- 36-254406
- 36-254407
- 36-254408
- 36-254409
- 36-254410
- Exp. 8/5/2023
- 36-255219
- 36-255220
- 36-255221
- 36-255222
- 36-255223
- Exp. 8/7/2023
- 36-255420
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 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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