The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0267-2021·Announced 2021-03-03

CareFusion Recalls ChloraPrep Antiseptic Applicators for Potential Fungal Contamination

CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, despite the lack of reported illnesses.

Plain-English summary

CareFusion 213, LLC is recalling 280 cartons of ChloraPrep One-Step 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol Non-Sterile Solution. The affected product consists of 0.10 fl. oz. (3ml) applicators, 25 per carton, with NDC 054365-400-01 and Catalog No. 260400. The recall is limited to climatic Zone IV regions, specifically Puerto Rico and Oman.

The recall is being conducted because the product is non-sterile and may be exposed to labeled storage conditions of 30°C/75% Relative Humidity for more than 6 months in these regions. Under these conditions, there is a potential for the growth of Aspergillus penicillioides, a type of fungus, which can result in a breach of the package integrity. Specific lots affected include, but are not limited to, Lot # 0192894 (Exp. 06/30/2023) and Lot # 9080812 (Exp. 03/31/2022).

Consumers and healthcare facilities in Puerto Rico and Oman should stop using the recalled product and contact CareFusion 213, LLC for further instructions or a return. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Antiseptic Applicators
Hazard
Affected units
280

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)

  • Exp. 06/30/2023
  • 9080812 Exp 03/31/2022

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 recalled by CareFusion 213, LLC 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 4 products in this recall →

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