FDA

Fungal contamination triggers recall of surgical prep applicators

February 19, 2025

BD (Becton, Dickinson and Company) announced a voluntary worldwide recall of one lot of ChloraPrep Clear 1 mL applicators due to the risk of fungal contamination. Aspergillus penicillioides can grow and contaminate the surface of the applicator under some conditions and poses a significant risk of serious systemic infections, sepsis, and other severe health complications if introduced into the bloodstream or surgical sites. ChloraPrep applicators are applied to the skin to prepare the site before invasive procedures, aiming to lower infection risk. The recall affects Lot# 3200240 (NDC# 54365-400-31), which expires on June 30, 2026, and has been distributed since September 2023. Physicians are advised to immediately discontinue use of the affected lot, which hasn’t been associated with any reported adverse events, and follow appropriate disposal protocols to prevent potential patient harm.

Source:

(2025, February 18). FDA. BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-worldwide-recall-one-lot-chlorapreptm-clear-1-ml-applicators-due-fungal