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B Braun Medical Inc Recall 89784

Description: 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 Recall 89784 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0872-2022
Event ID89784
Event DescriptionConductivity 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).
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity80
Recall ReasonFirm 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.
Device Classification20220420
Device Code InfoLots 4/21 and 5/21
Center Classification Date20220414
Recall Initiation Date20220128
Recalling FirmB Braun Medical Inc
Initial Notification Letter
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