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

Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis — recall Z-0518-2019

U.S. FDA — Device Enforcement · United States · 2018-10-09 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0518-2019
Date of alert
2018-10-09
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Fresenius Medical Care Renal Therapies Group, LLC
Product category
device
Product type
Devices
Reported risk: Discolored powder has confirmed the presence of a foreign substance
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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