FDA-Device2022-04-20Class II
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
B Braun Medical Inc
Hazard
Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
Sold states
US Nationwide distribution.
Affected count
80
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not applicable) and 710500K (UDI Not applicable).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0872-2022Don't want to check this manually?
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