FDA MedWatch: ChloraPrep 3 mL Applicator by BD Recall

 

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA Recalls webpage.  TOPIC: ChloraPrep 3 mL Applicator by BD: Recall Due to Potential Fungal Contamination with Aspergillus penicillioides in Specific U.S. Territories and Countries AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: BD (Becton, Dickinson and Company) is recalling 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). Based on internal product quality testing, BD identified that storage of the ChloraPrep 3 mL applicators exposed to temperatures of 30°C (86°F) 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. This recall is limited to the U.S. territories and countries listed below. This recall does not affect any other ChloraPrep product presentations, regardless of geography. To date, no adverse events or deaths have been reported related to this recall.

BACKGROUND: Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional and 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, requiring of 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.

RECOMMENDATION: Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.