BD ChloraPrep applicators recalled due to Fungal Contamination, USA

United States

BD (Becton, Dickinson, and Company) today 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. This lot was distributed globally beginning in September 2023.

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.

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 into the patient's bloodstream during the placement of an intravascular catheter. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs. The product is used for the preparation of the patient's skin prior to surgery and helps to reduce bacteria that potentially can cause skin infections.

Affected Product Details
- NDC Number: 54365-400-31
- Product Name: BD ChloraPrep™ Clear - 1 mL Applicator
- Catalog (REF) Number: 930480
- Lot Number: 3200240
- Expiry Date: 06/30/2026
- Package Size: 1 Applicator per Pouch, 60 Applicators per Inner Carton, 4 Inner Cartons per Case

The affected lot (3200240) can be identified by locating the above-referenced catalog and lot number on the lidding of the product package and the side of the individual shelf box and shipper box. Please immediately discontinue the use of the affected lot.

This recall should be carried out at 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 products listed.

Company name: BD
Brand name: BD
Product recalled: ChloraPrep Clear 1 mL applicator skin preparation product
Reason of the recall: Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicilliosis
FDA Recall date: February 18, 2025