FDA Device recall Z-0295-2016
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147 by Fresenius Medical Care Renal Therapies Group, citing dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0295-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-23 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis.
Reason
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Identifiers
| code_info | All 132 Gallon Granuflo Dissolution Units and 132 Gallon Dry Acid Dissolution Units with the H218 Motor and Modified H218 Mixer Motors. |
|---|
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-0295-2016%22
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