Reported Mar 2, 2016 · Terminated
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate…
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- Fresenius Naturalyte
- Liquid Acid Concentrate Catalog Number08-2301-3
- Intended UseAcid Concentrate for Bicarbonate Dialysis
- Lot codes and dates
- Lot Number15STAC072
- Exp Date2017-12-31
- Amount recalled
- 848 (212 cases)
Where it was sold
Why it was recalled
On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
This product could cause temporary or reversible health problems — stop using it.
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