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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73744

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 01, 2016
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
B Braun Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 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.

Z-1531-2016
Recall number
Z-1531-2016
Initiated
April 01, 2016
Classification
Class I
Status
Terminated
Recalling firm
B Braun Medical Inc
Quantity
370 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential leakage of conductivity sensors of the Dialog Dialysis machines.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Code information

Product Code 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.

Distribution pattern

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

device · product 2 of 6

Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 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.

Z-1532-2016
Recall number
Z-1532-2016
Initiated
April 01, 2016
Classification
Class I
Status
Terminated
Recalling firm
B Braun Medical Inc
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential leakage of conductivity sensors of the Dialog Dialysis machines.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Code information

Product Code 710200K, Serial Number Range; 202169 - 203249

Distribution pattern

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

device · product 3 of 6

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 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.

Z-1533-2016
Recall number
Z-1533-2016
Initiated
April 01, 2016
Classification
Class I
Status
Terminated
Recalling firm
B Braun Medical Inc
Quantity
318 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential leakage of conductivity sensors of the Dialog Dialysis machines.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Code information

Product Code 710200S Serial Number Range; 200805-204001

Distribution pattern

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

device · product 4 of 6

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 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.

Z-1534-2016
Recall number
Z-1534-2016
Initiated
April 01, 2016
Classification
Class I
Status
Terminated
Recalling firm
B Braun Medical Inc
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential leakage of conductivity sensors of the Dialog Dialysis machines.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Code information

Product Code 710200 USerial Number Range; 202136-203837

Distribution pattern

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

device · product 5 of 6

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.

Z-1535-2016
Recall number
Z-1535-2016
Initiated
April 01, 2016
Classification
Class I
Status
Terminated
Recalling firm
B Braun Medical Inc
Quantity
68

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential leakage of conductivity sensors of the Dialog Dialysis machines.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Code information

Item # 3456102A

Distribution pattern

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

device · product 6 of 6

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A 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.

Z-1536-2016
Recall number
Z-1536-2016
Initiated
April 01, 2016
Classification
Class I
Status
Terminated
Recalling firm
B Braun Medical Inc
Quantity
147

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential leakage of conductivity sensors of the Dialog Dialysis machines.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Code information

Item # 3456103A

Distribution pattern

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