CLASS II Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Conductivity Sensors utilized on Dialog recalled by B Braun Medical

B Braun Medical is recalling Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems, distributed nationwide in the US. The recall was initiated on 28 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 4/21 and 5/21

Quantity recalled80

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0872-2022
FDA event ID: 89784
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 Jan 2022
FDA classified: 14 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

28 Jan 2022	Recall initiated by company
14 Apr 2022	Classified by FDA	+76 days
20 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lots 4/21 and 5/21

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89784

This product is part of a recall event; the main page for the event is Conductivity Sensors utilized on Dialog recalled by B Braun Medical.

Reported	Class	Recall	Company	Reason	Where
20 Apr 2022	CLASS II	Conductivity Sensors utilized on Dialog recalled by B Braun Medical	B Braun Medical	Lead & Heavy Metals	Nationwide

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