Recall Z-1536-2016— B Braun Medical Inc
Class I · Terminated
Class I FDA medical device recall by B Braun Medical Inc, initiated 2016-04-01, terminated 2017-07-11. It names 2 FDA 510(k) clearances: K083460, K963440. Product: Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.. Reason: Potential leakage of conductivity sensors of the Dialog Dialysis machines..
- Recalling firm
- B Braun Medical Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-04-01
- Terminated
- 2017-07-11
- Firm location
- Bethlehem, PA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Reason for recall
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Data sourced from openFDA. This site is unofficial and independent of the FDA.