Agency classClass IIOur severity:High FDA (Drugs)·D-1037-2023·Announced 2023-08-09

Cardioplegia Solution Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 356 bags of cardioplegia solution distributed nationwide. The recall is due to lack of assurance of sterility, as validation data for decontamination cycles is lacking.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 high-risk injectable product used directly in critical cardiac surgery where sterility is essential. The recall is based on lack of sterility assurance (validation data for decontamination cycles is lacking). However, no illnesses or injuries have been reported and no contamination has been confirmed, classifying this as a theoretical risk-of-harm situation and qualifying for Score 3 per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte (NDC: 72196-0211-1) distributed nationwide. The recall involves 356 bags.

The product is being recalled due to lack of assurance of sterility. Specifically, validation data for decontamination cycles is lacking. This validation is necessary to ensure the product is free from microbial contamination.

Cardioplegia solution is an IV medication administered directly during cardiac surgery. The affected lot numbers and expiration dates are: 36-251457 (Exp. 7/14/2023), 36-253952 (Exp. 7/20/2023), 36-255944 (Exp. 7/27/2023), and 36-257101 (Exp. 7/31/2023). Healthcare providers should reference the FDA recall notice for guidance on this product.

The recalled product

Product: Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, 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 — Surgical Pharmacy / Injectable
Hazard: sterility-failure
contamination-risk
Affected units: 356

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 (8)

Lot: 36-251457
Exp. 7/14/2023
36-253952
Exp. 7/20/2023
36-255944
Exp. 7/27/2023
36-257101
Exp. 7/31/2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 95 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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