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.  

Affected Product

BD Convenience Kits and Procedure Trays

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:

What to Do

Do 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.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Image of an affected Sodium Chloride ampule and related labeling.

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.

Device Use

Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.

Contact Information

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.

Additional FDA Resources  

  • Related Downstream Recalls 

Unique 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 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.