The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1511-2020·Announced 2020-08-26

CareFusion Chlorhexidine Applicators Recalled for Non-Sterility

CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

CareFusion 213, LLC is recalling ChlroraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) 3 mL Applicators. The recall is due to the presence of Aspergillus Penicilloides, which renders the product non-sterile.

The affected product is manufactured by CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Company. The recall covers 4,272,300 applicators distributed to Puerto Rico, Guam, and various international locations including the United Arab Emirates, Bahrain, Brazil, and the United Kingdom.

Healthcare providers and consumers should stop using the affected lots immediately. The specific lot numbers and expiration dates are listed in the official recall documentation.

The recalled product

Product
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Surgical Prep
Hazard
Affected units
4,272,300

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 #: 7240735
  • Exp. Date 08/09/2020
  • 7235540
  • Exp. Date. 08/06/2020
  • 7297579
  • Exp. Date 10/08/2020
  • 8003727
  • Exp. Date 11/29/2020
  • 8011688
  • 8012808
  • Exp.. Date 12/18/2020
  • 8095620
  • 8087784
  • Exp. Date 03/31/2021
  • 8106737
  • 8130509
  • Exp. Date 04/30/2021
  • 8165721
  • 8187644
  • Exp. Date 06/30/2021

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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