Agency classClass IOur severity:Severe FDA (Drugs)·D-0266-2021·Announced 2021-03-03

CareFusion Recalls Non-Sterile ChloraPrep Solution Due to Microbial Contamination Risk

CareFusion 213, LLC is recalling non-sterile ChloraPrep With Tint solution distributed in Puerto Rico and Oman due to potential fungal contamination.

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 source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of at least 4 (Severe). The hazard involves potential fungal contamination leading to package breach in a non-sterile medical product.

Plain-English summary

CareFusion 213, LLC has initiated a Class I recall of ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution. The affected product is the Hi-Lite Orange variant, packaged as 0.10 fl. oz. (3 ml) applicators with 25 per carton. A total of 36 cartons are involved in this recall effort.

The recall addresses a potential microbial contamination issue. Specifically, there is a risk that Aspergillus penicillioides, a type of fungus, may grow on the product if it is stored at the labeled conditions of 30°C/75% Relative Humidity for more than six months. This fungal growth could result in a breach of the package integrity.

The recalled lots include but are not limited to Lot # 0038209 (Expiration Date: 01/31/2023) and Lot # 0098528 (Expiration Date: 02/28/2023). These products were distributed in Zone IV regions, specifically Puerto Rico and Oman. The recall was issued under FDA Drug Safety and Availability guidelines.

The recalled product

Product: ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Manufacturer: CareFusion 213, LLC
Category: Drug — Antiseptic Solution
Hazard: microbial-contamination
package-breach
Affected units: 36

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 (3)

Exp. 01/31/2023
0098528
Exp. 02/28/2023.

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 →

Same manufacturer · CareFusion 213, LLC

See all →

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ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
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ChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
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Same hazard · microbial contamination