CLASS I Device recall · Reported 11 May 2016 · FDA Enforcement Report

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) recalled

B Braun Medical is recalling Dialog+ Hemodialysis machines: Conductivity Sensor (BIC), distributed nationwide in the US. The recall was initiated on 1 Apr 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesItem # 3456102A

Quantity recalled68

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-1535-2016
FDA event ID: 73744
Recalling firm: B Braun Medical, Bethlehem, PA
Classification: Class I
Status: Terminated
Recall initiated: 1 Apr 2016
FDA classified: 3 May 2016
Reported: 11 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

1 Apr 2016	Recall initiated by company
3 May 2016	Classified by FDA	+32 days
11 May 2016	Published in enforcement report	+8 days

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

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

Where it was distributed

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI

Nationwide Alabama Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Maryland Missouri North Dakota New Jersey New Mexico New York Ohio

Questions about this recall

Why was it recalled?

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Which lots are affected?

Item # 3456102A

Where was it sold?

Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 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

5 other products · FDA event 73744

This product is part of a recall event; the main page for the event is Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product recalled.

Reported	Class	Recall	Company	Reason	Where
11 May 2016	CLASS I	Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product recalled	B Braun Medical	Packaging Defects	Nationwide
11 May 2016	CLASS I	Dialog+ Hemodialysis machines recalled by B Braun Medical	B Braun Medical	Packaging Defects	Nationwide
11 May 2016	CLASS I	Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) recalled	B Braun Medical	Packaging Defects	Nationwide
11 May 2016	CLASS I	Dialog+ Hemodialysis machines recalled by B Braun Medical	B Braun Medical	Packaging Defects	Nationwide
11 May 2016	CLASS I	Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product recalled	B Braun Medical	Packaging Defects	Nationwide

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