By IDSE News Staff
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 A. penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the healthcare professional and then consequently the sterile field. Since the applicator is used for site preparation before 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.
Contamination of skin preparation products with A. 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. A. 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 before surgery, helps to reduce bacteria that potentially can cause skin infection and is packaged in a pouch (one applicator per pouch, 60 applicators per inner carton).
| Product Name | Catalog (REF) Number | Lot Number | Expiry Date | Product Package Size |
| BD ChloraPrep Clear - 1 mL Applicator | 930480 | 3200240 | 6/30/2026 | 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 as well as the side of the individual shelf box and shipper box. 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.
This recall should be carried out to the distributor, hospital and user levels. BD is instructing distributors to identify all customers within its distribution network who may have purchased any of the affected product listed.
Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s Complaint Center: (844) 823-5433 (toll free) Monday to Friday between the hours of 9 a.m. and 6 p.m. ET or by emailing: productcomplaints@bd.com.