Granuflo / NaturaLyte
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29
March
2012
Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate
Recall Class: Class I
Date Recall Initiated:
March 29, 2012Product: Naturalyte and Granuflo Acid Concentrate
Use: The Naturalyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
Recalling Firm:
Fresenius Medical Care North America
920 Winter Street
Waltham, MA 02451
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.
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FDA Comments:
On March 29, 2012, the firm sent an Urgent Product Notification to their clinics and customers. This notification provided clinicians with prescribing information regarding the Naturalyte Liquid and Granuflo Acid Concentrate.Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
How can you seek compensation?
An Experienced Law Firm Can:
- Help you recover medical expenses and lost income from all responsible parties.
- Help you obtain records, case information, legal documents and photographs related to your case.
- Track down witnesses that must be found and asked for testimony regarding your Personal Injury case.
- Guide you through each step of the legal process and will help minimize potential disruptions to your life so you can focus on your recovery.
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- Help educate you about your case and the state laws involved.
- Make sure that your Personal Injury case is filed within the statute of limitations for your state.
- GranuFlo and NaturaLyte litigation is complicated and can involve large sums of money. A personal injury lawyer can make sure that you get compensation.
- Can usually tell within a few minutes whether they can help you, and if they can't, maybe direct you to someone who can.
Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
GranuFlo and NaturaLyte Side Effects
The FDA has requested Fresenius Medical Care to issue a Naturalyte Liquid Acid Concentrate recall and a Naturalyte GranuFlo recall after receiving a complaint about alkali dosing errors.
- Low blood pressure
- Heart attack
- Heart problems
- Cardiopulmonary arrest
- Metabolic alkalosis
- Stroke
- Death
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