Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis… — Class II medical device recall Z-0920-2014
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2014-02-12, distributed nationwide. Bicarbonate Jug Adapter distributed prior to 510(k) approval
| Recall number | Z-0920-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2013-12-17 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2021-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 703 units |
| Model numbers | 650103 |
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 for recall
Bicarbonate Jug Adapter distributed prior to 510(k) approval
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0920-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.