Class III — Fresenius Medical Care Holdings, Inc.
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Container cap may contain foreign material- 0.60% - 0.80% Manganese |
| 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. |
| Quantity | 12 bottles |
| Distribution | Distributed in the state of MO. |
| Initiated | 2014-05-01 |
| Classified | 2014-06-09 |
| Terminated | 2016-06-15 |
| Recall number | Z-1739-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Fresenius Medical Care Holdings, Inc. (Z-1739-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68135/
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