Drug recall
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the…
FDA recall event 93886 · Class II · NxStage MDS Corporation
Key facts
| Event ID | 93886 |
|---|---|
| Recall numbers | Z-1191-2024 |
| Recalling firm | NxStage MDS Corporation |
| Product type | Devices |
| Products | NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare… |
| Initiation date | Jan 29, 2024 |
| Report date | Mar 6, 2024 |
| 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: