Drug recall
PrisMax System, Product Code 955626
FDA recall event 89823 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 89823 |
|---|---|
| Recall numbers | Z-0991-2022, Z-0992-2022, Z-0993-2022 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | PrisMax System, Product Code 955626, PrisMax System, Product Code 955724, PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return… |
| Initiation date | Mar 15, 2022 |
| Report date | May 4, 2022 |
| 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: