The Recall Desk
HighFDA (Drugs)·D-1111-2023·Announced 2023-09-06

Cardioplegia Solution Recalled Due to Lack of Sterility Assurance

Central Admixture Pharmacy Services recalls Cardioplegia Solution due to inadequate validation of sterilization processes. One lot (36-262881) distributed nationwide may not be assured sterile.

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: FDA Class II classification indicates a serious defect with potential for patient harm in cardiac surgery applications. No reported illnesses or injuries have been documented; the hazard is a lack of validated sterilization assurance rather than confirmed contamination.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte (NDC 72196-0211-1) supplied in 1,047 mL EVA bags. Lot 36-262881 with expiration date 8/27/2023 is affected. One hundred bags were distributed nationwide.

The recall was initiated due to lack of validation data for sanitization cycles. This means the manufacturer cannot provide assurance that the sterilization process was adequately validated, creating a potential loss of sterility assurance for the product.

Cardioplegia solution is a critical medication administered during cardiac surgery to protect the heart during the procedure. Any contamination of this sterile product could result in serious patient harm.

Healthcare facilities that received this product should immediately identify and quarantine Lot 36-262881. Facilities should contact Central Admixture Pharmacy Services, Inc. for instructions on product return or disposal, and should notify the FDA's MedWatch program if the product was distributed or used.

The recalled product

Product
Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Cardiac Surgery Injectable
Hazard
  • sterility-defect
  • 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# 36-262881
  • Exp 8/27/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

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