The Recall Desk
HighFDA (Devices)·Z-0872-2022·Announced 2022-04-20

Conductivity Sensors in Dialog Hemodialysis Systems May Crack and Leak

B Braun Medical Inc is recalling conductivity sensors used in Dialog and Dialog+ hemodialysis systems due to potential cracks that could cause dialysate circuit leaks, affecting ultrafiltration during treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The hazard is a potential device malfunction with patient safety implications but no actual harm documented, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

B Braun Medical Inc is recalling Conductivity Sensor (BIC) VERSION 2 components (Article Code 3456102A) used with Dialog and Dialog+ hemodialysis machines. The affected units include lots 4/21 and 5/21, totaling 80 units with nationwide U.S. distribution.

The sensors may develop cracks during normal use, which could lead to a leak in the dialysate circuit. A leak in this circuit could result in excessive ultrafiltration or insufficient ultrafiltration, depending on whether the dialysis machine is equipped with a dialysis fluid filter.

No injuries or illnesses have been reported. Healthcare providers should inspect their equipment for cracks in the conductivity sensors and remove affected units from service immediately. Facilities should contact B Braun Medical Inc regarding replacement parts and further instructions.

The recalled product

Product
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
Manufacturer
B Braun Medical Inc
Category
Medical Device — Hemodialysis Equipment
Hazard
Affected units
80

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lots 4/21 and 5/21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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