FDA Device recall Z-0920-2014
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103 by Fresenius Medical Care Holdings, citing bicarbonate Jug Adapter distributed prior to 510(k) approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0920-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-17 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
Reason
Bicarbonate Jug Adapter distributed prior to 510(k) approval
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-0920-2014%22
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