ChloraPrep Clear 1 mL applicator skin preparation product

  • Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
  • Company: BD
  • Drugs
  • FDA
  • February 15, 2025

Product details

  • ChloraPrep Clear 1 mL applicator skin preparation product

Company announcement

BD (Becton, Dickinson and Company) has voluntarily recalled one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination.

The contamination involves Aspergillus penicillioides. This recall is worldwide. No adverse events have been reported to date.

The expiry date is June 30, 2026. The product is used for skin preparation prior to surgery.

Risk:

Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness, and death. If the fungus is introduced in the patient’s bloodstream during placement of an intravascular catheter, the catheter would most likely have to be removed, necessitating another procedure. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs.

Impacted states: Nationwide

Products:

- BD ChloraPrep™ Clear - 1 mL Applicator (UPC code(s): 5436540031)

Contact

For more information, call 1-844-823-5433 or email productcomplaints@bd.com.

View the original FDA notice

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