Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product… — Class I medical device recall Z-1532-2016
Terminated recall by B Braun Medical Inc, reported 2016-05-11, distributed nationwide. Potential leakage of conductivity sensors of the Dialog Dialysis machines.
| Recall number | Z-1532-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2016-04-01 |
| Classified | 2016-05-03 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 40 units |
| Reason classes | packaging |
| Serial numbers | 203249 |
Product
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.
Reason for recall
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1532-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.