BD Voluntary Recalls One Lot of ChloraPrep Clear 1 mL Applicators
MedTech company issues a risk statement, noting fungal contamination.
Becton, Dickinson and Company (BD), a medical technology (MedTech) company that produces and sells medical devices, laboratory equipment, and diagnostic products, is voluntarily recalling one lot of its ChloraPrep Clear 1 mL Applicators, due to fungal contamination.1 Under certain environmental conditions, the growth of Aspergillus penicillioides was reported.
As a result of the Aspergillus penicillioides entering the packaging, the actual surface of applicator becomes contaminated—along with the gloved hands of the healthcare professional that’s handling it—which then taints the sterile field. ChloraPrep Clear is used during the site preparation process before an invasive procedure takes place, so having a contaminated applicator can result in the patient potentially infected with the fungus.
The recalled lot began distribution in September 2023, but no customer complaints—nor adverse events—pertaining to this specific issue have been reported.
BD issued the following risk statement in respond to the contamination:
“Contamination of skin preparation products with Aspergillus 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. Aspergillus penicillioides infection of a surgical site may result in the need for medical and surgical interventions and long-term treatment with antifungal drugs.”
To the right is the referenced catalog and lot number (3200240) on the lid of the package, along with the shelf and shipper boxes. It’s important to discard of any product that it’s included in the affected lot and the prepared standard operating procedures should be followed at distributor, hospital, and user levels.
In other BD news, the medical technology company intends to separate BD's biosciences and diagnostic solutions business from the rest of the brand2 as a way—company executives say—in order to “enhance strategic focus and growth-oriented investments and capital allocation for both BD and the separated business and enhance value creation for shareholders.”
"Our BD 2025 strategy has transformed the company into a faster-growing, more profitable organization positioned at the forefront of long-term growth trends in health care, and we believe today's announcement is an exciting next step in unlocking significant potential value for all our stakeholders," commented Tom Polen, BD’s chairman, CEO, and president. "We believe the separation will position New BD as a differentiated MedTech leader and enable optimized investment to accelerate our innovation pipeline and ongoing margin enhancement through BD Excellence to further fund growth.
“We believe biosciences and diagnostic solutions is expected to deliver substantial value as a pure-play leader in life sciences and will be well-positioned to execute on its unique and compelling solutions and growth opportunities. This transaction is designed to position both businesses to thrive in our respective sectors and deliver value for shareholders."
References
1. BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination. BD. February 15, 2025. Accessed February 17, 2025. https://news.bd.com/2025-02-16-BD-Announces-Voluntary-Worldwide-Recall-for-One-Lot-of-ChloraPrep-TM-Clear-1-mL-Applicators-Due-to-Fungal-Contamination
2. BD Announces Intent to Separate Biosciences and Diagnostic Solutions Business to Enhance Focus, Drive Growth and Unlock Value. BD. February 5, 2025. Accessed February 17, 2025. https://news.bd.com/2025-02-05-BD-Announces-Intent-to-Separate-Biosciences-and-Diagnostic-Solutions-Business-to-Enhance-Focus,-Drive-Growth-and-Unlock-Value
