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High risk Medical DevicesClass II

ChloraPrep FREPP Applicators Recall

ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTIO

Updated June 11, 2026

ChloraPrep FREPP sterile skin antiseptic applicators were distributed without proper sterilization, posing a risk of infection. These applicators are used before medical procedures and must be sterile to prevent contamination.

Is the CareFusion 213, LLC recalled? Yes. This product was recalled by FDA on June 11, 2026. Details below.

What is recalled

ChloraPrep FREPP, Clear (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol), 500 x 1.5 mL applicators per case, NDC 54365-400-30, Catalog number 930599NSB, manufactured by CareFusion 213, LLC in El Paso, TX.

Am I affected

You are affected if you have ChloraPrep FREPP applicators with NDC 54365-400-30 or Catalog number 930599NSB that were received outside the intended distribution channel (such as through an unexpected supplier or distributor).

What to do right now

Stop using these applicators immediately. Contact your medical facility's purchasing or infection control department to report any ChloraPrep FREPP applicators in your inventory with NDC 54365-400-30 or Catalog number 930599NSB. Do not use them on patients.

The hazard

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Brands affected

CareFusion 213, LLC
Source
FDA
Category
Medical Devices
Recall ID
fda-D-0646-2026
Classification
Class II
Recalled
June 11, 2026
Read the official notice

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