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

Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL… — recall Z-1533-2016

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

As described by U.S. FDA — Device Enforcement: Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 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

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1533-2016
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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
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.

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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.