power cord for: — Class II medical device recall Z-2597-2018
Terminated recall by Baxter Healthcare Corporation, reported 2018-08-08. There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord
| Recall number | Z-2597-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2018-07-12 |
| Classified | 2018-08-02 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2021-03-31 |
| Countries outside the US | JP |
| Quantity | 5,445 units |
| Reason classes | device malfunction |
Product
power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
Reason for recall
There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket.
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-2597-2018. 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.