Recall Z-1316-2023
Baxter Healthcare Corporation · initiated February 22, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Codes / lots: Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Reason for recall
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-1316-2023
- Initiated
- February 22, 2023
- Posted by FDA
- April 1, 2023
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Quantity
- 16 units
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL