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Matthews Legal News

FDA Recalls GranuFlo & NaturaLyte

Recall initiated March 29, 2012

 

Blame Doctors' Math for Granuflo?

Fresenius Medical Care does

 

FMC & Sodium Diacetate

Hemodialysis Patients Need Perfect Balance

 

"Dear Doctor" Letter too little too late

Fresenius (FMC) too slow to respond

 

  


Matthews Legal News

FDA Recalls GranuFlo & NaturaLyte

Posted by Administrator (admin) on Nov 21 2012 at 11:14 AM
Matthews Legal News >>

A Class I recall is the most serious form the FDA can issue. Here is the language from the FDA's web site:

Reason for Recall:

The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

Click the link below to see the FDA's March 29, 2012 recall information for GranuFlo and NaturaLyte.

FDA Recall information

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