PlainRecalls
FDA Devices Critical Class I Terminated

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 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 a

Reported: May 11, 2016 Initiated: April 1, 2016 #Z-1536-2016

Product Description

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 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.

Details

Recalling Firm
B Braun Medical Inc
Units Affected
147
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
Location
Bethlehem, PA

Frequently Asked Questions

What product was recalled? ▼
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 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.. Recalled by B Braun Medical Inc. Units affected: 147.
Why was this product recalled? ▼
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2016. Severity: Critical. Recall number: Z-1536-2016.

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