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FDA Classifies BD Dialysis Convenience Kit Correction as Class I

FDA classified BD's correction of specified dialysis convenience kits and procedure trays as Class I because they contain sodium chloride ampules affected by a separate recall over product-quality and sterility-assurance concerns.

Type
Recall Brief
Published

Decision support

Decision summary

Official recall information is separated from MedTech Current editorial analysis.

Official recall information

What happened

FDA classified BD's correction of specified dialysis kits and procedure trays as Class I on September 24, 2026. The kits may contain 0.9% sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Elevaris Medical Devices because of product-quality and sterility-assurance concerns. FDA states that the ampule is the affected component and that remaining kit components may continue to be used after the ampule is removed. As of July 29, BD had reported no serious injuries or deaths associated with the issue.

MedTech Current analysis

Why it matters

Compromised sterility may expose patients to microorganisms, endotoxins, or foreign matter and may lead to serious infection or other complications, particularly in vulnerable patients. The kits and trays are used during dialysis procedures, so organizations need to identify the specified lots and remove the affected ampule while preserving the sterility of the remaining components.

Actions by role

MedTech Current analysis — editorial interpretation, not FDA-authored guidance.

  • MedTech Current analysisHealthcare facilitiesCheck inventory against FDA's full product and lot listings, quarantine affected kits until over-labels are available, and ensure staff follow the point-of-use correction instructions.
  • MedTech Current analysisDistributorsIdentify downstream customers for affected products and communicate the official notice.
  • MedTech Current analysisClinical usersConfirm an alternative sodium chloride source is available before the procedure and protect the sterile barrier when correcting the kit.

Official recall information

Official actions

According to FDA and BD's customer instructions:

  • Do not use sodium chloride ampules contained in affected kits or trays; check stock and quarantine affected products until over-labels are provided.
  • Apply labels without covering regulatory or traceability information or compromising the sterile barrier.
  • Secure an alternative local sodium chloride source before entering the procedural environment.
  • At the point of use, remove and destroy the ampule in a controlled and sterile environment; the remaining kit components may continue to be used after removal.
  • If an affected ampule was previously used without issue, no additional treatment or clinical follow-up is required; report incidents and take necessary action if use was associated with an issue.
  • Distributors should identify customers that received affected products and provide BD's customer communication.

Detailed recall information

Detailed sourced information from the published Recall Brief follows.

What changed

Becton Dickinson (BD) is correcting specified dialysis convenience kits and procedure trays that may contain 0.9% sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Elevaris Medical Devices. FDA classified BD’s action as a Class I recall on September 24, 2026. The sodium chloride ampule is the affected component; FDA says remaining kit components may continue to be used after it is removed.

FDA’s communication explains that compromised sterility may expose patients to viable microorganisms, endotoxins, or foreign matter and could cause serious complications. As of July 29, BD had reported no serious injuries or deaths associated with the issue.

Who and what are affected

FDA Recall Event ID 99534 includes two recall records: Z-2984-2026 for specified Power-Trialysis and Power-Trialysis Slim-Cath dialysis kits and procedure trays, and Z-2985-2026 for specified BD Acute Dialysis trays, including DuoGlide and Niagara configurations. FDA lists 149,521 units and 22,980 units in commerce for the respective records. The FDA recall database identifies Bard Access Systems, Inc. as the recalling firm. Only specified references and lots are affected; consult the FDA notice and database records for full product, UDI, and lot details.

What affected organizations should do

Healthcare facilities and clinical users

According to BD’s customer communication, do not use the sodium chloride ampules in affected kits. Check stock and quarantine affected kits until over-labels are provided. Secure an alternative sodium chloride source before entering the procedural environment. At the point of use, remove and destroy the ampule in a controlled, sterile environment; the remaining kit components may be used after removal.

If an affected ampule was previously used without issue, FDA states that no additional treatment or clinical follow-up is required. Report any incident through institutional processes and take appropriate action if a prior use was associated with an issue.

Distributors

Identify customers that received affected products and provide BD’s customer communication, as specified in the FDA recall records.

MedTech Current analysis

The correction applies to the saline ampule inside specified kits and trays, rather than automatically requiring disposal of every unaffected component. Product identification and sterile handling during ampule removal are central to the correction. Facilities should confirm the exact reference and lot scope against FDA’s records before acting.