The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding Avid Medical's recommendation to remove certain IV Start Kits from use due to potential fungal contamination stemming from recalled BD ChloraPrep applicators.
Avid Medical said that specific convenience kits containing the recalled BD ChloraPrep applicators should be removed. The contamination risk involves Aspergillus penicillioides, which may grow under certain environmental conditions. This action updates a July 22 notification, incorporating additional recall details from BD (Becton, Dickinson and Company) concerning their ChloraPrep Clear 1 mL Single Sterile applicators (BD lot 4032183).
Contamination with Aspergillus penicillioides can lead to serious health consequences, including systemic infection, sepsis, illness, and death. Introduction of the fungus into a patient's bloodstream during catheter placement could necessitate catheter removal and additional procedures, while surgical site infections may require medical and surgical intervention, alongside long-term antifungal treatment.
As of August 20, Avid Medical has not reported any serious injuries or deaths related to this issue. The FDA said, "CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available."