Avid Medical has recalled its medical supply kits, citing a risk of contamination with the fungus Aspergillus penicillioides from one of the devices in the kit.
The kits contain a set of devices used in routine medical care, such as draining fluid from a patient's chest and changing surgical dressings.
The Virginia-based supply maker said June 25 that each of the kits includes a Chloraprep applicator made by Becton Dickinson, designed to sanitize skin before surgery or catheter procedures.
The Chloraprep applicator carries a risk of being contaminated with the fungus, according to Avid Medical. If a contaminated device is used on a patient, it carries a risk of serious systemic infection, sepsis, illness and death, the FDA said. The agency classified the recall as class I, the most serious type of recall, meaning use of the product could cause serious injuries or death.
Avid Medical said there have been no deaths, complaints or reported injuries related to the recall.
Read the full news release here.