Z-1531-2016Class I

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

Name: Z-1531-2016 Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The...
Creator: B Braun Medical Inc
Published: 2016-04-01
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2016-04-01 / Terminated / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring... on 2016-04-01. FDA classified it as Class I and gives the reason as "Potential leakage of conductivity sensors of the Dialog Dialysis machines". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1531-2016
Classification: Class I
Status: Terminated
Initiated: 2016-04-01
Posted: 2016-05-03
Terminated: 2017-07-11
Recalling firm: B Braun Medical Inc
Product: 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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.
Quantity in commerce: 370 units
Distribution: 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
Product codes and lots: Product Code 710200L, Serial Number Range 200318 -203922 distributed between 08/05/2013 - 07/07/2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1531-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1531-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03
Z-1532-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03
Z-1533-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03
Z-1534-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03
Z-1535-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03
Z-1536-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-03

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)