The Recall Desk
CriticalFDA (Drugs)·D-1510-2020·Announced 2020-08-26

CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility

CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which is the highest level of recall classification indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep With Tint (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 indicates the product is not sterile.

The affected product includes 2,800,800 applicators in cartons of 25. The recall covers multiple lots with expiration dates ranging from June 2020 to January 2023. The product was distributed in Puerto Rico, Guam, and various international locations including the United Arab Emirates, Brazil, and the United Kingdom.

Consumers and healthcare facilities should stop using the affected applicators and contact CareFusion for instructions on return or disposal. The FDA has classified this as a Class I recall.

The recalled product

Product
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Manufacturer
CareFusion 213, LLC
Category
Medical Device — Surgical Prep
Hazard
Affected units
2,800,800

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 #: 7194739
  • Exp. 06/25/2020
  • 7214841
  • Exp. Date 07/17/2020
  • 7213558
  • Exp. Date 07/16/2020
  • 7227839
  • Exp. Date 07/30/2020
  • 7276589
  • Exp. Date 09/20/2020
  • 7198824
  • Exp. Date 06/29/2020
  • 7275718
  • Exp. Date 09/19/2020
  • 7289776
  • Exp. Date 09/30/2020
  • 7306916
  • Exp. Date 10/12/2020
  • 8011665
  • Exp. Date 12/14/2020

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 →

Related recalls

Same manufacturer · CareFusion 213, LLC

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Same hazard · non sterility

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