Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of sterility assurance and insufficient validation data for sterilization 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 recall of an injectable medical product with a gap in sterility assurance. No illnesses or injuries have been reported. The hazard is potential microbial contamination due to validation gaps in sterilization processes, which fits the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling a cardioplegia solution (Lot 36-254914, expiring July 22, 2023) distributed nationwide. The product is a 500 mL injectable solution used during cardiac surgery.
The recall was initiated because the manufacturer lacks assurance the product meets sterility standards. Validation data for the decontamination cycles used during sterilization is insufficient.
All 28 bags of the affected lot were distributed nationwide. Healthcare facilities that received this product should discontinue use and confirm that no units from this lot have been administered to patients.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0009-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance-failure
- contamination-risk
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 (2)
- Lot: 36-254914
- Exp. 7/22/2023.
Distribution
Distributed nationwide across the United States.
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