Cardioplegia Solution del Nido Formula Recalled for Lack of Sterility Assurance

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.

Category

Drug — Cardiac perfusion solution

Hazard

• contamination-risk
• missing-validation

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.

Distribution

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