Z-1316-2023 Class II Ongoing
FDA device recall Z-1316-2023 was initiated by Baxter Healthcare Corporation on Feb 22, 2023 and is designated Class II. Reason for recall: The electrical safety testing was not properly performed on the impacted devices and additional testing is required The recall status is ongoing. Affected quantity: 16 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 5, 2023
- Initiation Date
- Feb 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product description
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Reason for recall
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Distribution pattern
US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1316-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026