BD (Becton, Dickinson and Company) announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.
The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional and then consequently the sterile field. Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues. This lot was distributed globally beginning in September 2023. To date, there have been no reported customer complaints or adverse events associated with this issue.
Risk Statement: 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.
For more information about the recall, click here.
