Drug recall
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
FDA recall event 91776 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 91776 |
|---|---|
| Recall numbers | Z-1316-2023 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| Initiation date | Feb 22, 2023 |
| Report date | Apr 5, 2023 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: