FDAFDA · Food and drugs·Recall number Z-1532-2016
Dialog+ Hemodialysis machines: Dialog 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 system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Published May 11, 2016 · Recall initiated: April 1, 2016
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
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI
- Lot
- Product Code 710200K, Serial Number Range; 202169 - 203249
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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