FDA raises an Avid Medical IV start kit removal to Class I over a BD applicator lot

FDA classified Avid Medical's removal of an IV start kit as Class I on October 14, its most serious category. The listing names one product: IV START KIT NON-STERILE, item AVID KIT KRIV26-02, kit lot 1658437, UDI 10809160460481. The kit contains BD ChloraPrep Clear 1 mL single sterile applicators from BD lot 4032183, which BD recalled over possible fungal contamination that can allow Aspergillus penicillioides to grow.

Avid first notified customers on July 22 and told them to over-label the kit. On August 20 it replaced that instruction with destroying the entire kit after completing a response form. FDA issued an early alert on August 28. Avid had reported no serious injuries or deaths as of August 20. FDA says contaminated applicators can lead to systemic infection, sepsis, illness and death, and points to Enforcement Report event 99114 for the underlying BD recall.

Medline removed convenience kits over the same ChloraPrep applicators, which FDA posted a day earlier on October 13. Both kit assemblers are now carrying a recall they did not cause.

A kit assembler inherits the recall class of the worst component in the box, and the corrective action it chooses becomes the record FDA revisits. Avid's move from over-labeling to destruction is the detail that turned a July notification into an October Class I, which is an argument for making the harder call on the first letter.

Questions & Answers

Why did FDA classify the Avid Medical IV start kit recall as Class I?

The kit, item AVID KIT KRIV26-02 lot 1658437, contains BD ChloraPrep Clear 1 mL single sterile applicators from BD lot 4032183 that may be contaminated with the fungus Aspergillus penicillioides. FDA assigned the Class I designation on October 14, 2026 because contaminated applicators can cause systemic infection, sepsis and death.

What should customers do with the recalled Avid Medical IV start kit?

FDA says to check inventory for IV START KIT NON-STERILE item AVID KIT KRIV26-02 lot 1658437, quarantine it, complete the Avid Medical response form, then destroy the entire kit. This replaced an earlier instruction to over-label the kit, which Avid changed on August 20, 2026.

Which other company recalled convenience kits over the BD ChloraPrep applicator recall?

Medline also removed convenience kits containing the recalled BD ChloraPrep applicators. FDA posted the Medline convenience kit recall on October 13, 2026, one day before the Avid Medical Class I classification.

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