GranuFlo is a Dialysis medication which has been recalled due to the dangers of Cardiac arrest. Dialysis medication lawyers are filing lawsuits for victims and families of people who have been severly injured or died from immediate heart attacks from Fresenius' GranuFlo and Naturalyte.
Dialysis Statistics by State
New Hampshire: 690
New Jersey: 10,580
New Mexico: 2,451
New York: 23,612
North Carolina: 12,895
North Dakota: 501
Rhode Island: 838
South Carolina: 7,199
South Dakota: 689
West Virginia: 1,794
FDA GranuFlo Recall Notice
Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate
Recall Class: Class I
Date Recall Initiated: March 29, 2012
Product: Naturalyte and Granuflo Acid Concentrate
Serial numbers for Naturalyte Liquid Acid Concentrate range from:
08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8, 08-3201-4, 08-3231-1, 08-3251-9, 08-3301-2, 08-4123-1, 08-4223-7, 08-4225-1, 08-4230- 2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1, 13-3251-9, 13-4123-1, 13-4220-1, 13-4225-1, 13-4325-1
Serial numbers for Naturalyte GranuFlo (powder) Acid Concentrate range from:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-38, OFD2220-3B, OFD2223-3B, OFD2225-3B, OFD2231-3 B, OFD2251-3B, OFD2301-3B, OFD2323-3 B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B
This concentrate was manufactured and distributed from January 2008 through June 2012.
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.
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.
FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.
Consumers may contact the firm at 1-800-662-1237.
FDA District: New England District Office
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.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products.
If you or a loved one has been injured by these dialysis medications contact us immediately for a Granuflo lawyer.
We have GranuFlo lawyers ready to help you: Auburn AL; Birmingham AL; Dothan AL; Gadsden AL; Huntsville AL; Mobile AL; Montgomery AL; Muscle Shoals AL; Tuscaloosa AL; Anchorage AK; Fairbanks AK; Juneau AK; Flagstaff AZ; Sedona AZ; Mohave County AZ; Phoenix AZ; Prescott AZ; Show Low AZ; Sierra Vista AZ; Tucson AZ; Yuma AZ; Fayetteville AR; Fort Smith AR; Jonesboro AR; Little Rock AR; Bakersfield CA; Chico CA; Fresno CA; Humboldt County CA; Inland Empire CA; Long Beach CA; Los Angeles CA; Mendocino (new) CA; Merced CA; Modesto CA; Monterey CA; O.C. 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