BD (Becton, Dickinson and Company) has voluntarily recalled one lot of ChloraPrep Clear 1 mL Applicators globally due to fungal contamination risk.
The product prepares the patient’s skin before surgery, helping reduce bacteria that can cause infections. It is packaged in pouches, with one applicator per pouch and 60 applicators per inner carton.
The contamination allows Aspergillus penicillioides to grow under specific environmental conditions, the medical technology firm said.
Aspergillus penicillioides in the packaging may contaminate the applicator’s surface or the healthcare professional’s gloves, potentially affecting the sterile field.
A contaminated applicator could introduce the fungus directly into tissues if used for site preparation before an invasive procedure.
The US Food and Drug Administration (FDA) has been notified about this recall.
The affected lot was distributed globally starting in September 2023.
No customer complaints or adverse events have been reported.
Contamination of skin preparation products with Aspergillus penicillioides can lead to serious systemic infections, sepsis, illness, and even death.
If introduced into the bloodstream during intravascular catheter placement, the catheter may need to be removed, requiring additional procedures.
Aspergillus penicillioides infection at a surgical site may necessitate medical and surgical interventions, along with long-term antifungal treatment.
The affected lot can be identified by checking the catalogue and lot number on the product package lidding, as well as the individual shelf and shipper boxes.
BD said that customers should immediately discontinue use of the affected lot. They should inspect all inventory locations within your facility and destroy all affected units according to the facility’s process.
If immediate destruction isn’t possible, the product should be quarantined until it can be properly disposed of, the medical technology firm said.
BD is instructing distributors to identify all customers in their network who may have purchased the affected product.
Recently, BD announced plans to divest its biosciences and diagnostic solutions business to sharpen its focus, improve growth investments, and create more value for shareholders.
The medical technology firm also reported a net income of $303m, or $1.04 per diluted share, for Q1 FY2025.
