Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1536-2016 — 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 pr

U.S. FDA — Device Enforcement · United States · 2016-04-01 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1536-2016
Date of alert: 2016-04-01
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: B Braun Medical Inc
Product category: device
Product type: Devices

Reported risk: Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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