B Braun Medical Inc 2022-04-20 Health serious FDA
Health · FDA · Recall #FDA-Z-0873-2022
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity… Recall
Issued April 20, 2022 · B Braun Medical Inc
In April 2022, B Braun Medical Inc recalled the Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact B Braun Medical Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- B Braun Medical Inc
- Category
- Health
- Recall date
- April 20, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-0873-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- B Braun Medical Inc has 23 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.