FDA recall Z-1316-2023

Baxter Healthcare Corporation · Class II · device

Product

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

Reason for recall

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

Distribution

US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.

Key facts

Status
Ongoing
Initiation date
2023-02-22
Report date
2023-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1316-2023