FDA Device recall Z-1316-2023
Automated Peritoneal Dialysis System
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Automated Peritoneal Dialysis System by Baxter Healthcare, citing the electrical safety testing was not properly performed on the impacted devices and additional testing is required.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1316-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-22 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA |
Product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Reason
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Identifiers
| code_info | Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103…Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1316-2023%22
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