FDA Device recall Z-2373-2015
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
- FDA Device
- Class II
- ongoing
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB by Fresenius Medical Care Holdings, citing expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2373-2015 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2015-07-16 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Reason
Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.
Identifiers
| code_info | Lots begin with: 15AMLB, 15BMLB, 15CMLB. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2373-2015%22
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