The Recall Desk
SevereFDA (Drugs)·D-0346-2021·Announced 2021-05-05

CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe).

Plain-English summary

CareFusion 213, LLC is recalling ChloraPrep With Tint 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol Non-Sterile Solution. The recall involves 6,869,400 cartons of the product, which contains 25 applicators per carton. The product was distributed nationwide in the USA and to several international locations, including Singapore, Chile, Oman, and Brazil.

The recall was initiated because, at labeled storage conditions of 30°C and 75% relative humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. While the solution itself is labeled as non-sterile, the applicators are sterile if the package is intact. The breach of package integrity compromises the sterility of the applicators.

Healthcare facilities and consumers should stop using the affected lots and return them to the distributor or manufacturer for credit. The affected lots have expiration dates ranging from March 2021 to February 2023.

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
6,869,400

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: 0011737
  • 1/31/2023
  • 0020739
  • 0023790
  • 0037278
  • 0037279
  • 0038209
  • 0044734
  • 12/31/2022
  • 0007625
  • 10/31/2022
  • 0007630
  • 8095632
  • 3/31/2021
  • 8116723
  • 4/30/2021
  • 8127657
  • 8135651
  • 5/31/2021
  • 8137527

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 · microbial contamination

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