Reported Jan 20, 2021 · Ongoing
Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - 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 drums
- Product Code 13-2251-0 - 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 Numbers20LXAC025 20LXAC081 20LXAC082 20LXAC083
- Additional Affected lots as of 3/17/21
20LXAC02920NXAC02120LXAC02620LXAC06520LXAC02820NXAC02920LXAC07120LXAC10320LXAC02720LXAC07020LXAC06720NXAC01920LXAC08220LXAC02520LXAC08120LXAC083
- Amount recalled
- 224 drums
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Fresenius Medical Care Holdings, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.