Recall archive / FDA device enforcement
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. — FDA record Z-1316-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 16 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1316-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Feb 22, 2023
- Center classification date
- Mar 30, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.