Drug recall
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage…
FDA recall event 80512 · Class II · NxStage Medical, Inc.
Key facts
| Event ID | 80512 |
|---|---|
| Recall numbers | Z-2793-2018 |
| Recalling firm | NxStage Medical, Inc. |
| Product type | Devices |
| Products | NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of… |
| Initiation date | Jun 11, 2018 |
| Report date | Aug 22, 2018 |
| Termination date | Apr 28, 2020 |
| City | Lawrence |
| State | MA |
| Country | United States |
| FEI number | 3003464075 |
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: