The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0265-2021·Announced 2021-03-03

FDA Recalls Chloraprep One-Step Due to Potential Fungal Growth

CareFusion 213, LLC is recalling Chloraprep One-Step applicators distributed in Puerto Rico and Oman due to potential fungal growth in hot, humid conditions.

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 classified this as an FDA Class I recall, which by rubric criteria mandates a minimum severity score of 4 (Severe).

Plain-English summary

CareFusion 213, LLC is voluntarily recalling 988 cartons of Chloraprep One-Step (Chlorhexidine Glucunate and Isopropyl Alcohol) sterile solution. The product is a topical antiseptic used for skin preparation. The recall affects specific lots distributed in Puerto Rico and Oman.

The recall is being issued because the product was stored in climatic Zone IV regions where temperatures and humidity exceeded labeled storage conditions for more than six months. These conditions created a potential for the growth of Aspergillus penicillioides, a type of fungus, which could result in a breach of the package integrity and compromise the sterility of the product.

Consumers and healthcare facilities in Puerto Rico and Oman should stop using the affected product and contact CareFusion 213, LLC for instructions on return or replacement. The recall includes all lots distributed in Zone IV, including but not limited to those listed in the official notice.

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
988

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 (7)

  • 0211068 Exp. 07/31/2023
  • 0176660 Exp. 06/30/2023
  • 0188805 Exp. 06/30/2023
  • 0175874 Exp. 06/30/2023
  • 0151977 Exp. 05/31/2023
  • 0149328 Exp. 04/30/2023
  • 0085419 Exp. 03/31/2023

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 →

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