FDA recall Z-0550-2024

Baxter Healthcare Corporation · Class II · device

Product

Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479

Reason for recall

There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2023-11-15
Report date
2023-12-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0550-2024