The Recall Desk
HighFDA (Devices)·Z-0873-2022·Announced 2022-04-20

Hemodialysis Conductivity Sensors recalled for potential cracks and dialysate leaks

B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.

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 medical device with potential for harm (sensor cracking leading to circuit leaks and improper ultrafiltration). No illnesses or injuries have been reported to date. The theoretical nature of the hazard combined with the lack of reported incidents places this at Score 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

B Braun Medical Inc is recalling Conductivity Sensors (Conductivity Sensor END - VERSION 2, Article Code Number 3456103A) used as components or spare parts in Dialog and Dialog+ Hemodialysis Systems. The affected units are from lots 4/21 and 5/21, affecting 95 units with nationwide US distribution.

The sensors may develop cracks during normal use, which could result in a leak within the dialysate circuit. Depending on whether the dialysis machine is equipped with a Dialysis Fluid filter, this leak could lead to excessive ultrafiltration (removal of too much fluid) or insufficient ultrafiltration (removal of too little fluid). Both conditions represent improper machine function.

Patients currently using affected Dialog or Dialog+ hemodialysis machines should contact their healthcare provider or B Braun Medical Inc immediately. Healthcare facilities should verify the lot numbers on their equipment and follow manufacturer instructions for device verification and any required replacement.

The recalled product

Product
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. 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 — Dialysis Equipment
Hazard
  • crack
  • leak
  • malfunction

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.

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