Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of sterility assurance and missing decontamination validation data. The affected lot was distributed nationwide.
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: As a risk-of-harm sterile injectable product with no reported illnesses or injuries, this meets the High severity criterion per the rubric. The lack of sterility assurance on an injectable used in cardiac surgery poses significant risk of infection.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag (415 mL, NDC: 72196-0106-1). This is a prescription injectable solution used in cardiac surgery.
The FDA classified this as a Class II recall because the manufacturer cannot assure sterility of the product. Validation data for decontamination cycles is lacking, which means the sterilization process cannot be verified as adequate.
The affected lot is 36-251643 with an expiration date of 7/13/2023. A total of 48 units were distributed nationwide in the United States.
Healthcare facilities should verify whether they have this lot in inventory and discontinue use immediately if present. Healthcare professionals should contact Central Admixture Pharmacy Services, Inc. for guidance on product replacement and next steps.
The recalled product
- Product
- CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0106-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-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: 36-251643
- Exp. 7/13/2023
Distribution
Distributed nationwide across the United States.
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