FDA report “BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on June 23, 2020 of the ChloraPrep™ 3 mL applicator due to possible fungal contamination, which only affects climate zone IV regions in specific U.S. territories and countries (see list of catalog numbers and regions impacted by this issue below).
BD has identified that storage of the ChloraPrep™ 3 mL Applicator in regions of the world with high heat and humidity, where product may be consistently exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity for more than six months, may result in the growth of Aspergillus penicillioides. The recall does not apply to any states in the United States, it only applies to the U.S. territories of Puerto Rico, Guam, U.S. Virgin Islands, Northern Mariana Islands and American Samoa.
This recall does not include 3 mL applicators found in kits. It also does not include any other ChloraPrep™ product presentations. All other ChloraPrep™ products are manufactured with different packaging materials that are not affected by this issue.
As part of the voluntary recall to the user level, the company notified customers and distributors affected by the recall and provided guidance on the potential impact when the affected products were used.