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Class I

FDA calls BD's kit correction Class I over recalled saline ampules from a supplier

MedDevice Startups Staff · 1 day ago · 2 min read · Via FDA

FDA labeled Becton Dickinson's correction to convenience kits and procedure trays Class I on September 24. The kits carry sodium chloride ampules made by Huons Co., which were already under recall.

If sterility is compromised, the stated risk is local or systemic infection. BD reported no serious injuries or deaths tied to the issue as of July 29. The company told customers to stop using the ampules, label affected kits so staff can spot them, line up another saline source, and remove and destroy the ampule at the point of use while keeping the rest of the kit sterile. Every other component in the kit stays usable.

One purchased component pulled an entire kit line into the most serious recall class FDA has. Kit contents belong under the same supplier controls as the device they ship beside.

Questions & Answers

Why did FDA issue a Class I correction for Becton Dickinson convenience kits?

FDA designated Becton Dickinson's correction as Class I on September 24, 2026 because the affected convenience kits and procedure trays contain recalled sodium chloride ampules manufactured by Huons Co. If sterility is compromised, patients could face local or systemic infection.

Can hospitals still use the affected Becton Dickinson kits?

Yes. Becton Dickinson says every component other than the sodium chloride ampule remains safe to use. BD instructs customers to label affected kits, secure an alternative saline source, and remove and destroy the ampule at the point of use while maintaining sterility of the remaining components.

Were any injuries reported in the Becton Dickinson kit correction?

Becton Dickinson reported no serious injuries or deaths associated with the issue as of July 29, 2026.

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