CLASS II Device recall · Reported 20 Sep 2017 · FDA Enforcement Report

Baxter Amia Automated Peritoneal Dialysis Set with Cassette recalled

Baxter Healthcare is recalling Baxter Amia Automated Peritoneal Dialysis Set with Cassette, distributed nationwide in the US. The recall was initiated on 1 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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, H16K30015, H16L04034, H16L11039, H16L15105

Quantity recalled164,700 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3133-2017
FDA event ID: 78085
Recalling firm: Baxter Healthcare, Mountain Home, AR
Classification: Class II
Status: Terminated
Recall initiated: 1 Sep 2017
FDA classified: 14 Sep 2017
Reported: 20 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Sep 2017	Recall initiated by company
14 Sep 2017	Classified by FDA	+13 days
20 Sep 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

Where it was distributed

nationwide, Canada

Nationwide

Stores named: Walmart

Questions about this recall

Is Baxter Amia Automated Peritoneal Dialysis Set with Cassette recalled?

Yes. Baxter Healthcare recalled Baxter Amia Automated Peritoneal Dialysis Set with Cassette on 1 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-3133-2017.

Why was it recalled?

Which lots are affected?

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, H16K30015, H16L04034, H16L11039, H16L15105

Where was it sold?

nationwide, Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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