Avid Medical has recalled about 1,570 medical convenience kits that include BD/CareFusion ChloraPrep™ 3 mL applicators due to a risk of severe, life-threatening infections.
The recalled kits include certain Adult Chest Tube Trays, Fistula On-Off Kits, Fistula (On/Off All in One Bag), and Dialysis Access kits.
These kits also contain ChloraPrep™ 3 mL applicators, which were recalled by BD in June 2020 and again in March 2021 due to possible contamination with a common mold, Aspergillus penicillioides.
ChloraPrep is used to clean the skin of a patient before they undergo surgery. If it is contaminated with mold, there is a risk that the mold could enter a patient’s body during the surgery and cause an infection.
Patients may develop serious systemic infections, sepsis, illness, or death, according to the FDA. They may also need additional medical procedures, surgeries, or long-term treatment with anti-fungal medications.
On June 25, the FDA designated it a Class 1 recall — the most serious type of recall, reserved for devices that may cause serious injuries or death.
Source: Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination