FDA Advises Healthcare Professionals Not to Use BD’s ChloraPrep™ 3 ml Applicators
On March 19, 2021, the U.S. Food and Drug Administration (FDA) issued an advisory (https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-not-use-chloraprep-3-ml-applicators-manufactured-bd-becton) to healthcare professionals not to use ChloraPrep 3 ml applicators manufactured by BD (Becton, Dickinson and Company) because of the risk of microbial contamination. The product was distributed globally and is labeled with “CareFusion, El Paso, TX.”
The product was first recalled (https://www.bd.com/en-us/recall-notifications/detail-sur-20-1983#:~:text=On%20June%2023rd%2C%202020%2C%20Becton,for%20more%20than%20six%20months.) in June 2020 after users reported finding lid defects and fungal growth that breached the product seal. BD’s investigation confirmed that the product’s lid, when exposed to higher temperature and humidity, can fail and lead to microbial contamination, which may cause serious infections, especially in patients with compromised immune systems such as those receiving certain treatments for cancer. The product is used to sanitize the skin prior to surgery or catheter procedures. Healthcare professionals should use an available alternative.
The recall is categorized as class I, which FDA defined as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” If used on the skin before an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues which can cause a severe and potentially fatal medical condition.
FDA recommended on March 15, 2021, that BD expand the recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-recall-chlorapreptm-3-ml-applicator-specific-us-territories-and-countries) to include all unexpired ChloraPrep 3 ml applicators in all U.S. states. The company’s previous recall was limited to countries and U.S. territories with tropical climates. FDA is not aware of any adverse events associated with use of BD’s ChloraPrep 3 ml applicators.
For questions about the recall, contact BD customer support at 800-526-4455 from 8:30 am–6 pm ET.
Healthcare professionals and patients to report adverse events or quality problems experienced with the use of any medication to FDA’s MedWatch Adverse Event Reporting (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program) program:
Complete and submit the report online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm).
Download and complete the form (https://www.fda.gov/media/85598/download), then submit it via fax at 800-FDA-0178.