Agency classClass IIOur severity:High FDA (Drugs)·D-1015-2023·Announced 2023-08-09

Cardioplegia Solution IV Bags Recalled for Sterility Assurance Deficiency

Central Admixture Pharmacy Services is recalling Cardioplegia Solution IV bags (Lot 36-257024) due to lack of sterility assurance and insufficient validation of decontamination processes. Healthcare providers should discontinue use immediately.

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: The product is classified as FDA Class II. While no illnesses or injuries have been reported, the lack of sterility assurance and inadequate validation of decontamination cycles in an intravenous cardiac medication represents a risk-of-harm product without yet-reported injury, meeting the criteria for High severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution, IV Bag (Total Volume 1818 mL, Crystalloid Induction formulation, NDC 72196-0216-1, Lot 36-257024) that were distributed nationwide. The recall was initiated due to a lack of assurance of sterility and insufficient validation data for decontamination cycles.

Cardioplegia solution is administered intravenously during cardiac surgery to protect the heart during the procedure. The deficiencies in sterility assurance and decontamination validation create a potential risk of microbial contamination in the product.

Healthcare providers and hospitals that received the affected lot (36-257024, expiration 8/14/2023) should immediately discontinue use and contact Central Admixture Pharmacy Services, Inc. at their facility in Phoenix, Arizona for instructions on product return or replacement. Any adverse events associated with use of this product should be reported to the FDA.

The recalled product

Product: CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0216-1
Manufacturer: Central Admixture Pharmacy Services, Inc.
Category: Drug — Intravenous / Surgical
Hazard: sterility
validation-failure
Affected units: 48

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: 36-257024
Exp. 8/14/2023.

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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