Reported Jun 18, 2014 · Terminated
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number:…
Fresenius Medical Care Holdings, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Holdings, Inc. · 920 Winter St · Waltham, MA · 02451-1521
Is this the product you have?
- NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit
- Part Number08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
- Lot codes and dates
- Lot Number14CMLB006
- Amount recalled
- 12 bottles
Where it was sold
Why it was recalled
Container cap may contain foreign material- 0.60% - 0.80% Manganese
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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