Baxter Healthcare Corporation Recall 91776
Description: Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Baxter Healthcare Corporation Recall 91776 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1316-2023 |
| Event ID | 91776 |
| Event Description | Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. |
| Product Type | Devices |
| Distribution | US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA. |
| Quantity | 16 units |
| Recall Reason | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| Device Classification | 20230405 |
| Device 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. |
| Center Classification Date | 20230330 |
| Recall Initiation Date | 20230222 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Telephone |
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