The Recall Desk
CriticalFDA (Drugs)·D-1509-2020·Announced 2020-08-26

FDA Recalls Chloraprep One-Step Applicators Due to Non-Sterility

CareFusion 213, LLC is recalling 12,500 units of Chloraprep One-Step applicators because they are not sterile and contain Aspergillus Penicilloides.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for 12,500 units of Chloraprep One-Step (Chlorhexidine Gluconate and Isopropyl Alcohol) applicators. The product is manufactured by CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Company, located in El Paso, Texas. The specific product description is BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, NDC 54365-400-32.

The recall is being conducted because the product is not sterile and contains Aspergillus Penicilloides. The affected lots are 0065386 (Expiration Date: 2/28/2023) and 0091666 (Expiration Date: 3/31/2023). The distribution pattern includes Puerto Rico, Guam, the United Arab Emirates, Bahrain, Brazil, the Democratic Republic of the Congo, Chile, Colombia, the United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, and Singapore.

Consumers and healthcare providers should stop using the affected product immediately and contact CareFusion 213, LLC for a refund or replacement. This recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product may cause serious adverse health consequences or death.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical Antiseptic
Hazard
Affected units
12,500

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 #: 0065386 Exp. 2/28/2023
  • 0091666 Exp. 3/31/2023

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same brand · CHLORAPREP ONE-STEP

Same manufacturer · CareFusion 213, LLC

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Same hazard · non sterility

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