Baxter Amia Dialysis Set Recall: Missing Red Line and Flow Alerts
Baxter recalls Amia Automated Peritoneal Dialysis Sets with Cassette (lot numbers listed) due to missing red line and flow alerts. Affected users should check their lot numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Baxter is recalling certain Amia Automated Peritoneal Dialysis Sets with Cassette because they may show missing red line and flow alerts. This could lead to improper dialysis treatment if not addressed. Read more at govinfonow.com/recall/73085-baxter-amia-dialysis-set-recall-missing-red-line-and-flow.
Source Summary by GovInfoNow · govinfonow.com/recall/73085-baxter-amia-dialysis-set-recall-missing-red-line-and-flow · Updated September 18, 2026 · FDA enforcement record: FDA #Z-3133-2017
Cite this page
“Baxter Amia Dialysis Set Recall: Missing Red Line and Flow Alerts.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73085-baxter-amia-dialysis-set-recall-missing-red-line-and-flow. Based on FDA recall #Z-3133-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3133-2017%22&limit=1).
Why it’s dangerous
The device may show missing red line and flow alerts, which could indicate improper function. This might lead to inadequate dialysis treatment if the alerts are not addressed.
Who’s affected
Patients using the Baxter Amia Automated Peritoneal Dialysis Set with Cassette are affected. Those with the listed lot numbers are most at risk.
How to tell if you have this one
Check the lot number on the cassette. The affected lots are listed in the recall notice: H16G28107, H16H01086, and other specific numbers.
- Brand
Baxter- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the cassette to see if it's in the affected list.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “nationwide, Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3133-2017 (September 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3133-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.