Baxter Healthcare Corporation: Medical Device Recall in 2023 - (Recall #: Z-1316-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 22, 2023

Date Posted: April 5, 2023

Recall Number: Z-1316-2023

Event ID: 91776

Reason for Recall:

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

Status: Ongoing

Product Quantity: 16 units

Code Information:

Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated