Cardioplegia Solution Recalled for Lack of Sterility Validation

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 Pharmac

Manufacturer

Central Admixture Pharmacy Services, Inc.

Category

Drug — Injectable / Sterile Compounded

Hazard

• sterility-failure
• process-validation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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