Reported Jan 20, 2021 · Ongoing
Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius…
Fresenius Medical Care Holdings, Inc.
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 Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521
Is this the product you have?
- Naturalyte Liquid Acid concentrate bottles
- Product Code 08-2251-0 - Product Usageused in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine
- Lot codes and dates
- Lot Numbers20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010
- Additional Affected lots as of 3/17/21
20LXAC05320LXAC04720LXAC05420LXAC04920NXAC01620LXAC09420NXAC02420NXAC02520LXAC09120LXAC10120LXAC07720LXAC04820NXAC01020LXAC076
- Amount recalled
- 3083 cases
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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