FDAFDA · Food and drugs·Recall number Z-1739-2014
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part 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 June 18, 2014 · Recall initiated: May 1, 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
Container cap may contain foreign material- 0.60% - 0.80% Manganese
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Distributed in the state of MO.
- Lot
- Lot Number: 14CMLB006
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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