United States
Company name: (Becton, Dickinson and Company)
Brand name: ChloraPrep; BD ChloraPrep
Product recalled: ChloraPrep 3 mL Applicator
Reason of the recall: Potential Aspergillus penicillioides contamination
FDA Recall date: March 24, 2021
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology company, has revised its press release dated March 19, 2021 relating to an expanded 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 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.
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.
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 United States.
The implementation time for other countries will vary based on registration requirements. As part of the voluntary recall to the user level, the company will notify customers and distributors affected by the recall. BD is instructing customers and distributors to discard all remaining inventory of the impacted ChloraPrep™ 3 mL applicators (see list of impacted catalog numbers below) and committed to replacing product affected by the recall.
Check the full recall details on
www.fda.gov
Source: FDA
