Drug recall
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is…
FDA recall event 66953 · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 66953 |
|---|---|
| Recall numbers | Z-0920-2014 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Bicarbonate Jug Adapter distributed prior to 510(k) approval |
| Initiation date | Dec 17, 2013 |
| Report date | Feb 12, 2014 |
| Termination date | May 18, 2021 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: