Reported Sep 20, 2017 · Terminated

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

Baxter Healthcare Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corp · 1900 Highway 201 N · Mountain Home, AR · 72653-2433

Is this the product you have?

  • Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Lot codes and dates
  • 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
Amount recalled
164,700 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 27, 2019 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.