FDA Issues Early Alert for Becton Dickinson Kits with Recalled Sodium Chloride

The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding certain Becton Dickinson (BD) convenience kits that may contain recalled sodium chloride ampules. BD has advised affected customers to remove these components, manufactured by Huons Co., Ltd. and previously recalled by Elevaris Medical Devices, before using the kits.

BD said that these convenience kits and procedural trays might include the compromised sodium chloride ampules. If the sterility of the sodium chloride injection is compromised, patients face risks including exposure to microorganisms, endotoxins, and foreign matters. This could lead to systemic inflammatory responses, infections, micro-clots, and organ failure.

As of July 29, BD has not reported any serious injuries or deaths linked to this issue. The FDA's Center for Devices and Radiological Health (CDRH) emphasized the alert's importance, stating, "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."