Recalls / —

—#198832

Product

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

FDA product code

FKX — System, Peritoneal, Automatic Delivery

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K201867

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

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

Timeline

Recall initiated

2023-02-22

Posted by FDA

2023-04-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #198832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.