FDA alerts on possible Aspergillus contamination in Avid Medical IV start kits

The FDA’s Center for Devices and Radiological Health has issued an Early Alert warning that certain IV start kits from Avid Medical may be contaminated with the fungus Aspergillus penicillioides, a risk linked to the broader BD ChloraPrep Applicator recall.

The affected product is a non-sterile convenience kit identified as IV START KIT NON-STERILE, model AVID KIT KRIV26-02, lot number 1658437, with UDI 10809160460481.

On August 20, Avid Medical sent a letter to customers directing them to review inventory, quarantine the kits, and destroy the entire kit after completing response forms, replacing earlier July 22 guidance that only required over-labeling the kits for component removal.

Users are advised to remove any of these kits from use or sale immediately and follow the destruction instructions to eliminate the potential contamination risk.