Z-0873-2022Class II

Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION...

Name: Z-0873-2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION...
Creator: B Braun Medical Inc
Published: 2022-01-28
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2022-01-28 / Terminated / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These... on 2022-01-28. FDA classified it as Class II and gives the reason as "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...". 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-0873-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Posted: 2022-04-15
Terminated: 2024-05-15
Recalling firm: B Braun Medical Inc
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 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 17, 2022, the firm, B.Braun Medical Inc., mailed out Recall Customer Notification Letters to affected consignees. Distributors should notify affected customers. Customers should identify any affected products within the spare parts inventory of their facility, cease use, and quarantine the product. Do not destroy any affected product. If any machine exhibited repeated Alarm Code 1026 - "UF balance? Air leakage in dialyzer coupling" alarms, customer should discontinue therapy on the device and immediately quarantine the machine until it can be inspected and any impacted sensors replaced. Customers should inspect ALL Dialog+ and Dialog+ Evolution dialysis machines in their facility which may have been serviced with potentially impacted sensors. Once the firm receives the customer acknowledgement form, a representative will contact the customer on how to return impacted sensors and/or to schedule a time to inspect equipment. Customers with questions should contact B. Braun Avitum Technical Services at 1-800-21-0445.
Quantity in commerce: 95
Distribution: US Nationwide distribution.
Product codes and lots: Lots 4/21 and 5/21

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0873-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0872-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14
Z-0873-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-14

Product code KDI

K083460Class IIDialog with Adimea OptionB. Braun Avitum AG / cleared 2010-02-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)