TOPIC: ChloraPrep Clear 1 mL Applicators by BD: Recall - Due to Fungal Contamination
AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy
ISSUE: BD (Becton, Dickinson and Company) is recalling one lot (3200240) 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 this recall, click on the red button "Read Recall" below.
BACKGROUND: ChloraPrep Clear 1 mL applicators are used for the preparation of the patient’s skin prior to surgery and helps to reduce bacteria that potentially can cause skin infection.
RECOMMENDATIONS:
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Please immediately discontinue use of the affected lot. Check all inventory locations within your facility and destroy all affected units in accordance with your facility’s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal.
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This recall should be carried out to the Distributor, Hospital and User levels. BD is instructing distributors to identify all customers within their distribution network who may have purchased any of the affected product.
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Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s Complaint Center: 1-844-823-5433.
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