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The FDA is aware that Becton Dickinson (BD) has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use by removing components affected by the Huons Co., Ltd. recall.
BD stated that certain convenience kits and procedural trays may contain sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Elevaris Medical Devices.
If the sterility of the sodium chloride injection (flush solution) is compromised, patients may be exposed to viable microorganisms, endotoxins, and/or foreign matters generated during manufacturing. This can trigger systemic inflammatory responses, infections, micro-clots, and organ failure.
As of July 29, BD has not reported any serious injuries or deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact BD at productcomplaints@bd.com or (844) 823-5433.
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