FDAClass IMay 11, 2016

Dialog+ Hemodialysis machines: Conductivity Sensor recall

Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments…

Why was Dialog+ Hemodialysis machines: Conductivity Sensor recalled?

Potential leakage of conductivity sensors of the Dialog Dialysis machines.

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?

Item # 3456103A

Product
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments…
Recalling firm
B Braun Medical Inc
Quantity
147
Distribution
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
Recall date
May 11, 2016
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls