Becton Dickinson Issues Class I Recall For Huons Kits

A downstream recall cascade now reaches BD convenience kits and procedure trays used in dialysis settings, after Becton Dickinson confirmed that certain kits contain sodium chloride ampules manufactured by Huons Co., Ltd. and subject to an upstream recall by Elevaris Medical Devices. The FDA has classified this correction as Class I, its most serious designation, citing risk of serious injury or death if affected components remain in use.

BD notified affected customers by letter on August 10, directing facilities to quarantine kits containing the implicated ampules, apply over-labels for identification, and source alternative sodium chloride before entering the procedural environment. At the point of use, the ampule is to be removed and destroyed within a controlled, sterile environment to preserve the sterility assurance of the remaining kit components. All other components within the kits may continue to be used.

For QA directors managing supplier qualification programs, the event illustrates a specific compliance exposure: pharmaceutical components distributed through medical device kit channels fall under overlapping FDA recall jurisdiction, meaning a single upstream supplier failure can trigger correction actions across multiple finished device configurations. BD's kits span catheters, dressings, and pharmaceutical components intended for dialysis procedures, each with its own traceability requirements under 21 CFR Part 211 and device-side UDI obligations.

The sterility risk profile is consequential. If sterility is compromised, potential adverse health effects include local or systemic infection, sepsis, thrombosis, and organ dysfunction, with elevated exposure among vulnerable patient populations. As of July 29, BD had reported no serious injuries or deaths associated with the issue. Asymptomatic patients who received procedures using affected lots require no specific follow-up; patients presenting with adverse outcomes should receive appropriate medical evaluation.

Facilities holding affected stock should cross-reference BD's full affected product list against current inventory, confirm quarantine status, and document corrective actions within their CAPA systems before over-labels are received and applied. The related downstream recall involving Spectra Medical Devices sodium chloride flush products signals that the Huons upstream event continues to propagate through multiple distribution channels.

The measurable checkpoint for plant heads and QA leads is supplier qualification documentation: whether existing agreements with kit assemblers explicitly address recall notification timelines and component-level traceability when pharmaceutical ingredients are embedded in device configurations.

Source: FDA MedWatch Safety Alerts via FDA.gov, September 24, 2026.