Reported Jun 13, 2018 · Terminated
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This…
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?
- NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters
- Part Number08-3231-1
- Product UsageThis concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine
- For every 45 volume parts of dialysate1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used
- Lot codes and dates
- Lot Code18CXAC095
- Amount recalled
- 1060 cases (4240 bottles)
Where it was sold
Why it was recalled
The bottles are mislabeled with an incorrect part number.
This product could cause temporary or reversible health problems — stop using it.
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