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Open, Classified

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

FDA Recall Z-1316-2023 · Posted 2023-04-01

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFKX
Date Initiated2023-02-22
Product Quantity16 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation · 2020-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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