FDAFDA · Food and drugs·Recall number Z-2686-2014
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Published October 1, 2014 · Recall initiated: June 23, 2014
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
Product was held at temperature above the labeled recommended storage temperature
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Distributed in Texas.
- Lot
- Lot Number: 14BMLB012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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