Baxter Amia Automated Peritoneal Dialysis Set with Cassette — Class II medical device recall Z-3133-2017
Terminated recall by Baxter Healthcare Corp, reported 2017-09-20, distributed nationwide. The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, a
| Recall number | Z-3133-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp, Mountain Home, AR, United States |
| Recall initiated | 2017-09-01 |
| Classified | 2017-09-14 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2019-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 164,700 units |
| Lot numbers | H16G28107, H16H01086, H16H04114, H16H09063, H16H13032, H16H19112, H16H26034, H16H30010, H16I02017, H16I06018, H16I08071, H16I12016, H16I14103, H16I16066, H16I19060, H16I21058, H16I23047, H16I26065, H16I30091, H16J03014, H16J05035, H16J07015, H16J09078, H16J11132, H16J14011, H16J16057, H16J18046, H16J20109, H16J22063, H16J24127, H16J26072, H16J28128, H16J30058, H16K01057, H16K03079, H16K05041, H16K07054, H16K08086, H16K10090, H16K28027 and 4 more |
| Model numbers | 5C5479 |
Product
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Reason for recall
The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette.
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-3133-2017. 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.