BD has announced a voluntary worldwide recall of a single lot of ChloraPrep Clear 1mL applicators over contamination under specific environmental settings allowing the growth of the fungus Aspergillus penicillioides.
Aspergillus penicillioides in the packaging could lead to contamination of the applicator surface or the gloved hands of healthcare professionals, thereby potentially compromising sterile fields.
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The ChloraPrep applicator is used for skin site preparation before invasive procedures, and the presence of the fungus could result in direct inoculation into tissues.
The product is packaged in pouches, with one applicator per pouch and 60 per inner carton.
Distributed globally since September 2023, lot number 3200240 has not been associated with any reported customer complaints or adverse events to date.
However, BD has urged immediate discontinuation and destruction of the affected products in line with facility protocols.
According to the company, contamination of skin preparation products with this fungus could lead to severe systemic infections, sepsis, and other health risks, including death.
If introduced into the bloodstream during catheter placement, the contamination could necessitate catheter removal and additional medical procedures.
Infections at surgical sites may require extended antifungal treatments and further surgical interventions.
BD has instructed distributors to trace all customers within their supply network who purchased the impacted products. The recall extends to distributor, hospital, and user levels.
In December 2024, BD and Babson Diagnostics expanded their fingertip blood collection and testing technologies.
BD’s MiniDraw Capillary Blood Collection System, combined with Babson’s BetterWay technologies, enables testing from as little as six drops of blood taken from a patient’s finger.
