Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
This recall is currently active, issued April 1, 2023. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- February 22, 2023
- Posted
- April 1, 2023
- Recall Number
- Z-1316-2023
- Quantity
- 16 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Distribution
US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
Lot / Code Info
Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Root 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.