Drug recall
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following…
FDA recall event 81283 · Class II · Smiths Medical ASD Inc.
Key facts
| Event ID | 81283 |
|---|---|
| Recall numbers | Z-2554-2019 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Devices |
| Products | Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to… |
| Initiation date | Oct 15, 2018 |
| Report date | Oct 2, 2019 |
| Termination date | Oct 11, 2022 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3012307300 |
At a glance
- 1–9 Products in this recall
- 1–9 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: