FDA recall Z-3133-2017

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.

Distribution

nationwide, Canada

Key facts

Status

Terminated

Initiation date

2017-09-01

Report date

2017-09-20

Termination date

2019-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mountain Home, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3133-2017