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Fresenius Issues Class I Recall Of Hemodialysis Products

FDA Recall Status: Class I

Date at which recall was initiated: March 29, 2012

Product: Naturalyte and GranuFlo Acid Concentrate

The serial numbers for the Naturalyte Liquid Acid Concentrate ranges 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

The serial numbers for the Naturalyte GranuFlo Acid Concentrate (powder) ranges 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, OFD3301-3B

The dates for manufacture and distribution for these concentrates were from January 2008 to June 2012.

Use: The Naturalyte and Granuflo Dry Acid concentrate are used in the treatment of acute and chronic kidney failure during hemodialysis.  The concentrate is made to be used with a 3-stream hemodialysis machine, which is calibrated for bicarbonate and acid concentrates.

Recalling Firm:

Fresenius Medical Care North America

920 Winter Street

Waltham, MA 02451

Reason for the recall:

Fresenius Medical Care North America is cautioning clinicians and healthcare providers to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in the Naturalyte Liquid and GranuFlo Dry Acid Concentrate.  The inappropriate prescription and administration of these products can lead to a high serum bicarbonate level in a patient undergoing hemodialysis.  This can contribute to metabolic alkalosis, which is a significant risk factor closely associated with hypokalemia, hypotension, hypoxemia, hypercapnia and cardiac arrhythmias, which if gone on untreated, can result in cardiopulmonary arrest.  This product can cause serious adverse side effects, even death.

The FDA has issued a general safety communication related to the inappropriate prescription and administration resulting in alkali dosing errors in the dialysate concentrates used during hemodialysis.

Public Contact:

Consumers can contact the firm at 1-800-662-1237

FDA District:        New England District Office

FDA Comments:

As of March 29, 2012, Fresenius Medical Care North America had sent an Urgent Product Notification to clinicians and customers.  This notified them of prescribing information regarding these products.

Class I recalls are known to be the most serious type of recall and involve circumstances in which there’s a suspected probability that administration of these products can cause serious adverse side effects, even death.

Healthcare professionals and consumers can report adverse side effects or quality problems they’ve experienced while using these products to Medwatch: The FDA Safety Information and Adverse Event Reporting Program, either online, by postal mailing or by fax.