Baxter Healthcare Corp: Medical Device Recall in 2017 - (Recall #: Z-3133-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 1, 2017

Date Posted: September 20, 2017

Recall Number: Z-3133-2017

Event ID: 78085

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.

Status: Terminated

Product Quantity: 164,700 units

Code Information:

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

Distribution Pattern:

nationwide, Canada

Voluntary or Mandated:

Voluntary: Firm initiated