Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides

Company Name:
BD
Brand Name:
Product Description:

Product Description

ChloraPrep Clear 1 mL applicator skin preparation product

Company Announcement

FRANKLIN LAKES, N.J. (Feb. 15, 2025) – BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides.

The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional and then consequently the sterile field. Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues. This lot was distributed globally beginning in September 2023. To date, there have been no reported customer complaints or adverse events associated with this issue.

Risk Statement: 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.

The product is used for the preparation of the patient’s skin prior to surgery, helps to reduce bacteria that potentially can cause skin infection, and is packaged in a pouch (1 applicator per pouch, 60 applicators per inner carton).

Affected Product NDC 

Product Name 

Catalog (REF) Number 

Lot Number 

Expiry Date 

Product Package Size 

54365-400-31

BD ChloraPrep™ Clear - 1 mL Applicator

930480

3200240

6/30/2026

60 Applicators per Inner Carton 4 Inner Cartons per Case

The affected lot (3200240) can be identified by locating the above referenced catalog and lot number on the lidding of the product package and the side of the individual shelf box and shipper box. Please immediately discontinue use of the affected lot. Check all inventory locations within your facility and destroy all affected units in accordance with your facility’s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal.

This recall should be carried out to the Distributor, Hospital and User levels. BD is instructing distributors to identify all customers within their distribution network who may have purchased any of the affected product listed.

Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s Complaint Center: 1-844-823-5433 (Toll Free) Monday – Friday between the hours of 9 a.m. and 6 p.m. ET or by emailing: productcomplaints@bd.com.

The U.S. Food and Drug Administration (FDA) has been notified of this recall.

FDA MedWatch Reporting

Adverse reactions/events experienced with the use of any of these products should also be reported to the FDA's MedWatch Adverse Event Reporting program either online, phone or by regular mail.

  • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
  • Call 1-800-FDA-1088 (1-800-332-1088) • Regular Mail: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter) @BDandCo or Instagram @becton_dickinson.

Media:                                       Investors:
Troy Kirkpatrick                         Adam Reiffe
BD Public Relations                  BD Investor Relations
858.617.2361                            201.847.6927
Troy.Kirkpatrick@bd.com          adam.reiffe@bd.com