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

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 cen — recall Z-1534-2016

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-1534-2016
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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