Dear Valued Customer,
BD is initiating a voluntary recall for the ChloraPrep® One-Step 3mL Applicator – Clear, ChloraPrep® With Tint 3mL Applicator – Hi-Lite Orange, BD ChloraPrep™ Clear 3mL Applicator, and BD ChloraPrep™ Hi-Lite Orange 3mL Applicator.
BD has confirmed that the product catalog and lot numbers referenced in Attachment A (linked below) when stored continuously at 30°C / 75%RH for more than six months allows the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach in the package integrity.
The health consequences associated with the presence of the fungus, Aspergillus penicillioides, in the product packaging are potentially serious. The Aspergillus 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. There has been no identified risk associated with the sterile ChloraPrep™ antiseptic solution within the applicator.
To date, no complaints, adverse events, injuries, or deaths have been reported related to this voluntary recall.
Please click on the button below to read the full statement from BD and the list of products recalled.