Source: US Food & Drug Administration (FDA)

The FDA has recently updated its March 29, 2012 Class I recall of the dialysis products, Naturalyte Liquid and Granuflo Acid Concentrate.  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 Naturalyte Liquid 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.

Class I recalls are the most serious type of recall by the FDA and they involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The relevant 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 by Fresenius Medical Center, the largest operator of dialysis centers in the US.  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 (low calcium), hypoxemia (low oxygen), hypercapnia (too much carbon) and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

Consumers may contact the firm at 1-800-662-1237.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program1 either online, by regular mail or by FAX.

The Lewis Law Firm handles cases of defective drugs and medical devices.  If you or a loved one were injured by a defective durg or defective medicaldvices, including dialysis solutions, contact the Lews Law Firm for a FREE Consultation and Case Review, today.

Posted by Gayle R. Lewis, Esquire