Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules

The affected products and recommendations for what to do with the devices below have not changed. This recall involves correcting certain devices by removing recalled components. The FDA has identified this recall as the most serious type.

This device may cause serious injury or death if you continue to use it without correction.Affected Product 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.Affected devices:Various BD Convenience Kits and Procedure TraysFull List of Affected ProductWhat to DoDo not use sodium chloride ampules included in affected kits. Check your stock for convenience kits containing sodium chloride ampules and quarantine until over-labels are provided.

All remaining components within the kits may continue to be used.On August 10, BD sent all affected customers a letter recommending the following actions:Do not use the sodium chloride ampules contained within the affected kits. The sodium chloride ampule is the only impacted component within the kit/tray and all remaining components can continue to be safely used. Label all affected kits/trays to facilitate easy identification of products containing the affected ampules.Apply the labels to the product without covering or obscuring any regulatory or traceability information.Secure an alternative local sodium chloride prior to entering the procedural environment.

Upon opening the kit, remove and destroy the ampule from the BD convenience kits/procedure trays at the point of use, within a controlled and sterile environment to maintain the sterility of the remaining components within the kit.If affected sodium chloride ampule was previously used without issue, no additional treatment or clinical follow up is required.If affected sodium chloride ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions.For patients who have already undergone procedures using affected lots, no specific follow up is required for asymptomatic patients; individuals presenting with any adverse health outcomes related to the use of the sodium chloride ampules should seek appropriate medical evaluation.Reason for Correction 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 sterility is compromised, potential adverse health effects may include local or systemic infection, inflammatory reactions, sepsis, thrombosis, organ dysfunction, or other serious complications, particularly among vulnerable patient populations.As of July 29, BD has not reported any serious injuries or deaths associated with this issue.Device UseThe affected convenience kits contain catheters, dressings and/or other materials and pharmaceutical components that are intended to be used during dialysis procedures.Contact InformationCustomers 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.Additional FDA Resources FDA Enforcement Report CDRH Medical Device Recall DatabaseRelated Downstream Recalls Spectra Medical Devices Sodium Chloride Flush Recall: FDA Enforcement ReportHuons Co., Ltd.

Saline and Lidocaine Recall: FDA Enforcement ReportUnique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.Timeline of Communication UpdatesDateActions09/24/2026The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall and clarify the reason for correction.08/18/2026 The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.