Z-1316-2023 Class II Ongoing
FDA device recall Z-1316-2023 was initiated by Baxter Healthcare Corporation on February 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
- April 5, 2023
- Initiation Date
- February 22, 2023
- Termination Date
- N/A
- 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.