FDA Device recall Z-2150-2024
TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
- FDA Device
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-… by Outset Medical, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2150-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-30 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Outset Medical |
| Distribution | US |
Product
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 Hemodialysis System.
Reason
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, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.
Identifiers
| code_info | UDI-DI: 00850001011303. All PN-0006813 serial numbers with power cords: PN-0005746, PN-0006578, PN-0005747 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2150-2024%22
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