FDAFDA · Food and drugs·Recall number Z-0872-2022
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).
Published April 20, 2022 · Recall initiated: January 28, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- US Nationwide distribution.
- Lot
- Lots 4/21 and 5/21
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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