Automated peritoneal dialysis — Class II medical device recall Z-1565-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-05-04, distributed in NY. Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AM
| Recall number | Z-1565-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-02-16 |
| Classified | 2016-04-25 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-12-23 |
| Distributed | NY |
| Countries outside the US | EC |
| Quantity | 10 units |
Product
Automated peritoneal dialysis (APD) cycler
Reason for recall
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
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-1565-2016. 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.