The Recall Desk
SevereFDA (Drugs)·D-0348-2021·Announced 2021-05-05

ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no specific injuries are reported in the text, the potential for fungal contamination of a sterile medical product represents a significant risk of harm, aligning with the Severe classification for Class II recalls with significant potential consequences.

Plain-English summary

CareFusion 213, LLC is recalling 14,275,400 cartons of CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL). The product is a sterile solution containing 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, packaged with 25 applicators per carton. The recall is classified as FDA Class II.

The recall is being conducted because there is a lack of assurance of sterility. At the labeled storage conditions of 30°C and 75% relative humidity, there is the potential for the growth of Aspergillus penicillioides, a type of fungus. This growth could result in a breach of the package integrity, compromising the sterile status of the applicators.

The affected product was distributed nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil. Specific lot numbers and expiration dates are listed in the recall documentation. Consumers and healthcare providers should stop using the product and contact the manufacturer or their supplier for instructions on return or replacement.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Surgical Prep
Hazard
Affected units
14,275,400

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 (20)

  • Lot and Exp Date: 0018578
  • 11/30/2022
  • 0058277
  • 2/28/2023
  • 0059141
  • 0066365
  • 0067289
  • 3/31/2023
  • 0070866
  • 0074038
  • 0076034
  • 0084619
  • 0086158
  • 0090894
  • 0093903
  • 0095838
  • 0097561
  • 0098470
  • 0100383
  • 0109632

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Related recalls

Same brand · CHLORAPREP ONE-STEP

Same manufacturer · CareFusion 213, LLC

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Same hazard · fungal contamination

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