ChloraPrep™ 3 mL Applicators Recalled Due to Possible Fungal Contamination
FRANKLIN LAKES, NJ – A news article posted on marketscreener.com states that Becton Dickinson and B.D. has expanded its recall of their ChloraPrep™ 3 mL applicator product in all 50 United States. Skin preparation products contaminated with Aspergillus Penicillioides could result in sepsis or a severe systemic infection causing death.
Becton Dickinson and B.D., a preeminent global medical technology corporation is based in New Jersey, revised its March 19, 2021, press release relating to an expanded recall that began back on June 23, 2020, for certain catalog numbers of the company’s ChloraPrep™ 3 mL applicator due to potential Aspergillus Penicillioides fungal contamination under special environmental conditions.
B.D. also stated that storage of its ChloraPrep™ 3 mL Applicators in regions of the world with high heat and humidity encourage the growth of Aspergillus penicillioides. The release states that the ChloraPrep™ 3 mL Applicators should not be exposed to temperatures greater than 86 degrees Fahrenheit and relative humidity of 75% or greater to prevent the growth of Aspergillus penicillioides.
The recall notice also states that Aspergillus penicillioides within the product’s packaging might also contaminate the surface of the ChloraPrep™ 3 mL Applicator and/or the gloved hands of health care professionals and then contaminate the sterile field. ChloraPrep™ 3 mL Applicators are used for surgical site preparation. If a contaminated applicator is used during a procedure, the applicator will cause a direct inoculation of the fungus into the patient’s tissues.
If the Aspergillus penicillioides fungus enters into the patient’s bloodstream during intravascular catheter placement, the catheter would have to be removed, requiring another procedure. Aspergillus penicillioides infections of a surgical site can require medical and surgical interventions along with long-term antifungal drug treatment.
According to the recall announcement and revised recalls, the 3 mL applicators inside of the kits were not recalled. No other ChloraPrep™ product presentations were recalled.
The manufacturer is notifying all distributors and customers affected by this recall. B.D. is directing all of its distributors and customers to discard all unused inventory of the affected ChloraPrep™ 3 mL applicators, and the company will replace all products affected by the recall.
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