FDA Issues Early Alert on AVID Medical Kit Recall Over Fungal Contamination

The U.S. Food and Drug Administration (FDA) has issued an "Early Alert" concerning AVID Medical convenience kits, which are being recalled due to potential fungal contamination originating from BD ChloraPrep applicators. AVID Medical has advised customers to remove affected kits from where they are used or sold.

The contamination, identified as "Aspergillus penicillioides," poses a risk of serious adverse health consequences, including systemic infection, sepsis, illness, and death. Introduction of the fungus into a patient's bloodstream during intravascular catheter placement could necessitate catheter removal, while surgical site infections may require medical and surgical intervention and long-term antifungal treatment.

This action updates an initial AVID Medical notification from July 14, with revised recall details from BD regarding their ChloraPrep Clear 1 mL Single Sterile applicators (BD lot 4032183). As of August 6, AVID Medical has not reported any serious injuries or deaths associated with this issue. The FDA's Center for Devices and Radiological Health (CDRH) said it is issuing this "Early Alert" to notify the public of a potentially high-risk device issue and will provide updates.