Class II — 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 II |
| Status | Ongoing |
| Reason | Bacterial contamination. |
| Product | NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. |
| Quantity | 1,856,619 Bottles |
| Distribution | Nationwide Distribution |
| Initiated | 2015-05-20 |
| Classified | 2015-06-22 |
| Recall number | Z-1827-2015 |
| 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 II recall — Fresenius Medical Care Holdings, Inc. (Z-1827-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71160/
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