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Outset Medical, Inc. FDA Recalls
5 recalls on file across devices, 1 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indiClass IIAug 1, 2024Blood leak sensor, a component of hemodialysis device, may s |
| TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747Class IIApr 30, 2024A cart with prefiltration drawer, an optional hemodialysis s |
| Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001Class IMar 6, 2024Hemodialysis System, pre and post dialyzer peroxide-cured si |
| Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis Class IIJan 24, 2023An observed trend of high conductivity dialysate alarms in a |
| Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000Class IIJan 20, 2022Due to a component in the hemodialysis console there is the |