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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-D-0646-2026
- Classification
- Class II
- Recalled
- June 11, 2026
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