Drug recall
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot)…
FDA recall event 94654 · Class II · Outset Medical, Inc.
Key facts
| Event ID | 94654 |
|---|---|
| Recall numbers | Z-2150-2024 |
| Recalling firm | Outset Medical, Inc. |
| Product type | Devices |
| Products | TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat… |
| Initiation date | Apr 30, 2024 |
| Report date | Jun 26, 2024 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 3010355846 |
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: