The Recall Desk
HighFDA (Drugs)·D-0349-2021·Announced 2021-05-05

CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth may breach package integrity. The product was distributed in the US and 12 other countries.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a high-risk pathogen (Aspergillus penicillioides) with a potential for package integrity breach, but no illnesses or injuries have been reported.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution applicators. The recall involves 40,720,900 cartons of the product, which contains 25 applicators per carton. The product is manufactured by CareFusion 213, LLC and was distributed nationwide in the USA as well as to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. At the labeled storage conditions of 30°C and 75% relative humidity, there is a potential for the growth of Aspergillus penicillioides, a type of fungus. This fungal growth could result in a breach of the package integrity. The source text does not report any illnesses or injuries associated with this recall.

Healthcare facilities and consumers should stop using the affected product and check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. The affected lots have expiration dates ranging from March 31, 2021, to December 31, 2022. Users should contact the manufacturer or their supplier for further instructions on returning or disposing of the product.

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, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Antiseptic Applicators
Hazard
Affected units
40,720,900

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: 0000192
  • 12/31/2022
  • 0007621
  • 0008775
  • 0009111
  • 0011738
  • 0011753
  • 0011754
  • 0011755
  • 0013604
  • 0015498
  • 0015500
  • 0016329
  • 1/31/2023
  • 0017929
  • 0021945
  • 0028887
  • 0031093
  • 0034660
  • 0035149

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 manufacturer · CareFusion 213, LLC

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Same hazard · fungal growth

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