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FDA Issues Class 1 Recall of GranuFlo

Stephanie Dube4 years ago

The FDA has issued a Class 1 Recall of GranuFlo and Naturalyte liquid, popular dialysis products manufactured by Fresenius Medical Care (FMC). A Class 1 Recall is a serious recall in which the product could cause severe health risks or death.

The recall comes after the FDA issued a safety alert and began an investigation into why FMC did not warn all dialysis centers that its GranuFlo product could cause cardiac arrest when used improperly. Fresenius warned doctors at its own medical centers first, in Nov. 2011, and did not warn other centers until prompted by the FDA in March 2012.

Important Recall Information

  • The recall was issued for Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate
  • The product was manufactured January 2008 through June 2012.
  • A full list of serial numbers involved in the recall can be found on the FDA's recall page.
  • The products are used during dialysis treatment, in both Fresenius centers and other centers.

About the Injury

  • The products contain higher concentrations of a compound that creates bicarbonates in the blood than do similar dialysis products.
  • If doctors don't recognize the higher concentrations in these products and modify their prescriptions accordingly, patients could have dangerously high levels of bicarbonates in their blood.
  • Patients with high levels of bicarbonate in their blood have four to six times the risk of suffering cardiac arrest during dialysis.
  • Anyone who received GranuFlo during dialysis and suffered cardiac arrest, death, or heart damage might have been affected.
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