FDA MedWatch - ChloraPrep, 3 mL Applicator by BD: Expanded Recall -

Due to Potential Aspergillus penicillioides contamination

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: ChloraPrep, 3 mL Applicator by BD: Expanded Recall -  Due to Potential Aspergillus penicillioides contamination AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy  ISSUE: BD has revised its press release dated March 19, 2021 relating to an expanded recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep 3 mL applicator due to possible fungal contamination under certain environmental conditions. BD has determined that storage of the ChloraPrep 3 mL Applicator in regions of the world with high heat and humidity, where product may be exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity, allows 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. To date, no complaints, adverse events, injuries, or deaths have been reported related to this voluntary recall. For more information about this recall and the affected catalog numbers, click on the red button "Read Recall" below. BACKGROUND:  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. RECOMMENDATION: BD is instructing customers and distributors to discard all remaining inventory of the impacted ChloraPrep 3 mL applicators and is committed to replacing product affected by the recall. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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