Central Admixture Pharmacy Services recalls low potassium cardioplegia solution due to lack of sterility assurance. This product may cause infections if used improperly. Affected units have specific lot numbers and expiration dates.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services is recalling low potassium cardioplegia solution because it lacks proper sterility validation. This could lead to infections if the solution is used in medical procedures without adequate sanitation.
The solution may not be properly sanitized, which can lead to contamination. Without validated sanitization cycles, the risk of infection increases when the solution is used in medical procedures.
Healthcare professionals using this solution for cardiac surgery or medical procedures are affected. Patients receiving the solution through medical procedures are at risk of infection.
Check for lot number 36-262881 and expiration date 8/27/2023 on the EVA bag packaging. The product is labeled as Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume 1047 mL.
Look for lot number 36-262881 and expiration date 8/27/2023 on the EVA bag packaging.
The product may not be sterile due to lack of validated sanitization cycles, so it should not be used without proper testing.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Check for lot number 36-262881 and expiration date 8/27/2023 on the EVA bag packaging.
We’ve drafted a message you can send Central Admixture Pharmacy Services to request your refund or repair — edit it as you like.
Subject: Recall D-1111-2023 — Central Admixture Pharmacy Services Central Admixture Pharmacy Services Hello, I own a Central Admixture Pharmacy Services that is covered by recall D-1111-2023 from Central Admixture Pharmacy Services. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
