Reported May 11, 2016 · Terminated
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The…
B Braun Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B Braun Medical Inc · 824 12th Ave · Bethlehem, PA · 18018-3524
Is this the product you have?
- Dialog+
- Hemodialysis machinesDialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 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 systemHemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis
- Lot codes and dates
Product Code 710200KSerial Number Range202169 - 203249
- Amount recalled
- 40 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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