B Braun Medical Inc recalls Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 T

Recalled May 11, 2016 · FDA recall Z-1533-2016 · B Braun Medical

Hazard

Potential leakage of conductivity sensors of the Dialog Dialysis machines. · FDA Class I

Units

318 units

Sold at

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

Description

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Product

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 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.

Manufacturer(s)

B Braun Medical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →