The Recall Desk
HighFDA (Drugs)·D-0350-2021·Announced 2021-05-05

CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.

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. The hazard involves a potential breach of package integrity due to fungal growth, which poses a risk of harm to patients using the sterile applicators, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

CareFusion 213, LLC is recalling approximately 7,990,100 cartons of ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution. The product is distributed in 25-applicator cartons and is identified by NDC 054365-400-11 and Cat. No. 260415.

The recall was initiated 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 growth could result in a breach of the package integrity, which is critical because the applicators are sterile only if the package remains intact.

The affected lots were 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 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, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Antiseptic Applicators
Hazard
Affected units
7,990,100

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)

  • Lots and Exp dates: 0009104
  • 12/31/2022
  • 0013602
  • 0016431
  • 1/31/2023
  • 0022273
  • 0023788
  • 0029135
  • 0032694
  • 0038211
  • 0044741
  • 0064598
  • 2/28/2023
  • 0104862
  • 3/31/2023
  • 0127010
  • 4/30/2023
  • 0196060
  • 6/30/2023
  • 0224915

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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