Puerto Rico
Company name: (Becton, Dickinson and Company)
Brand name: (Becton, Dickinson and Company)
Product recalled: ChloraPrep™ 3 mL applicator
Reason of the recall: Potential fungal contamination - Aspergillus penicillioides
FDA Recall date: August 10, 2020
Recall details: BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on June 23, 2020 for specified catalog numbers 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. Through internal product quality testing, BD has identified that storage of the ChloraPrep™ 3 mL Applicators where product may be consistently exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity for more than six months can result in the growth of Aspergillus penicillioides, a type of fungus, resulting in a breach in the outer package integrity.
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. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious systemic infection, sepsis, illness and death. If the fungus is introduced into 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.
To date, no complaints, adverse events, injuries or deaths have been reported related to this voluntary recall. At the time of the recall, BD informed customers and distributors in the affected territories 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
