Product Wiki · Recalls · U.S. FDA — Device Enforcement

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. — recall Z-0682-2013

U.S. FDA — Device Enforcement · United States · 2012-11-26 · Class III

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0682-2013
Date of alert
2012-11-26
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Fresenius Medical Care Holdings, Inc.
Product category
device
Product type
Devices
Reported risk: GranuFlo Dry Acid Concentrate may show discoloration
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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