Conductivity Sensors utilized on Dialog and Dialog+ recall
Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These…
Why was Conductivity Sensors utilized on Dialog and Dialog+ recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots 4/21 and 5/21
- Product
- Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These…
- Recalling firm
- B Braun Medical Inc
- Quantity
- 80
- Distribution
- US Nationwide distribution.
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)