FDA Device recall Z-1739-2014
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit
- FDA Device
- Class III
- terminated
- Published 2014-06-18
On 2014-06-18 the FDA classified a Class III recall of NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit by Fresenius Medical Care Holdings, citing container cap may contain foreign material- 0.60% - 0.80% Manganese.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1739-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-05-01 |
| Published | 2014-06-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | MO |
Product
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Reason
Container cap may contain foreign material- 0.60% - 0.80% Manganese
Identifiers
| code_info | Lot Number: 14CMLB006 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1739-2014%22
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