BD expands voluntary recall of ChloraPrep 3 mL applicator to include all US states

BD (Becton, Dickinson and Company) has expanded a voluntary 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 continuously exposed to temperatures of 30 °C (86 °F) and 75% relative humidity for more than 6 months, allows the growth of Aspergillus penicillioides.

There has been no identified risk associated with the sterile ChloraPrep antiseptic solution within the applicator. Out of an abundance of caution and in consultation with the FDA, BD has expanded the recall to include all US. states. 

The FDA has designated the recall as Class I, which they define as a situation in which there is a reasonable probability that the use of the product may cause serious adverse health consequences or death. To date, no complaints, adverse events, injuries, or deaths have been reported related to this voluntary recall.

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.

BD is implementing a global packaging change for the 3 mL product to correct this issue, which is expected to be available by the end of April in the US. The implementation time for other countries will vary based on registration requirements.

The health consequences associated with the presence of the fungus, Aspergillus penicillioides, in the product packaging are potentially serious. 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. The presence of fungus in the tissues can cause a severe and potentially fatal medical condition.

As part of the voluntary recall to the user level, the company will notify customers and distributors affected by the recall.