Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
In a significant move to ensure patient safety, BD (Becton, Dickinson and Company) has announced a voluntary worldwide recall of one lot of its ChloraPrep™ Clear 1 mL Applicators due to potential fungal contamination. The affected product, used for skin preparation before surgeries and invasive procedures, may harbor Aspergillus penicillioides, a fungus that could lead to severe infections, sepsis, or even death if introduced into a patient’s bloodstream or surgical site.
The recall, which affects lot number 3200240 (expiry date June 30, 2026), was initiated after the company identified the risk of fungal growth under certain environmental conditions. While no customer complaints or adverse events have been reported to date, BD is taking proactive steps to mitigate potential harm.
The ChloraPrep™ Clear 1 mL Applicator is designed to reduce bacteria on the skin prior to surgery, helping to prevent infections. However, contamination with Aspergillus penicillioides could compromise its safety. If the fungus contaminates the applicator or a healthcare professional’s gloved hands, it could be transferred to the sterile field and directly into a patient’s tissues during a procedure.
The consequences of such contamination could be severe, including systemic infections, the need for surgical interventions, and long-term antifungal treatments. In cases involving intravascular catheters, contaminated applicators could necessitate catheter removal and additional procedures.
The affected lot was distributed globally starting in September 2023. BD is urging healthcare facilities, distributors, and users to immediately discontinue use of the recalled product and destroy or quarantine any remaining units. The product can be identified by the following details:
- NDC Number: 54365-400-31
- Catalog (REF) Number: 930480
- Lot Number: 3200240
- Expiry Date: 6/30/2026
- Package Size: 60 applicators per inner carton (4 inner cartons per case)
BD has instructed distributors to notify all customers who may have purchased the affected lot and is working closely with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to manage the recall.
Healthcare facilities are advised to check their inventory and destroy or quarantine the affected lot immediately. Patients who have undergone procedures using the recalled product should consult their healthcare providers if they experience any unusual symptoms or infections.
BD’s Complaint Center is available to address customer inquiries and reports of adverse reactions. Customers can contact BD at 1-844-823-5433 (toll-free) Monday through Friday, 9 a.m. to 6 p.m. ET, or email productcomplaints@bd.com. Adverse events should also be reported to the FDA’s MedWatch program online at www.fda.gov/medwatch/report.htm or by calling 1-800-FDA-1088.
