The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0345-2021·Announced 2021-05-05

CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination

CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage 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 FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, an FDA Class I classification mandates a severity score of at least 4.

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 product is distributed in 25-applicator cartons and is identified by NDC 054365-400-01 and Catalog Number 260400. The recall involves 11,115,774 cartons distributed nationwide in the USA and to several international locations including Singapore, Chile, Oman, Colombia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil.

The recall was initiated because the product is being recalled because at labeled storage conditions of 30°C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted 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 check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the instructions provided in the full recall documentation.

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.…
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Surgical/Procedural Antiseptic
Hazard
Affected units
11,115,774

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: 0008777
  • 12/31/2022
  • 0016325
  • 0021072
  • 1/31/2023
  • 0027041
  • 0030959
  • 0031090
  • 0044735
  • 0048062
  • 2/28/2023
  • 0052110
  • 0056365
  • 0086148
  • 0104864
  • 3/31/2023
  • 0192894
  • 6/30/2023
  • 8081571
  • 3/31/2021

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 →

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