FDAFDA · Food and drugs·Recall number Z-0516-2019
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Published December 5, 2018 · Recall initiated: October 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discolored powder has confirmed the presence of a foreign substance
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Distributor
- Distribution US nationwide and Mexico
- Lot
- Lot code:18ETGF005
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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