The Recall Desk
HighFDA (Drugs)·D-1036-2023·Announced 2023-08-09

Cardioplegia IV Solution Recalled for Sterilization Validation Deficiency

Central Admixture Pharmacy Services is recalling 88 bags of Cardioplegia Solution (Lot 36-255943) due to lack of assurance of sterility and insufficient validation of decontamination cycles. The product is used during cardiac surgery.

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 intravenous medication where sterility assurance is compromised. Although no illnesses or injuries have been reported, cardioplegia solution is a high-risk product administered directly into the heart during critical surgical procedures, making a sterility defect a significant risk of harm. The lack of validation data for decontamination cycles represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 88 bags of Cardioplegia Solution (20 mEq K, Maintenance 4:1, Low Potassium, 810 mL per bag) with Lot 36-255943 and expiration date of 7/27/2023. Cardioplegia solution is an intravenous medication used during cardiac surgery to preserve heart function.

The recall was issued because the manufacturer lacks assurance of product sterility and has not provided adequate validation data for decontamination cycles used in manufacturing. Because cardioplegia solution is administered directly into the heart during surgery, sterility is critical.

The product was distributed nationwide in the United States. Healthcare facilities that received this lot should discontinue use and contact the manufacturer for recall instructions and guidance.

The recalled product

Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous Medication
Hazard
  • contamination-risk
  • sterilization-failure

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: 36-255943
  • Exp. 7/27/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

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