Home › Outset Medical, Inc. › Tablo Needleless Cartridge, B
Tablo Needleless Cartridge, B
Outset Medical, Inc. · Model PN-0002572 · UDI-DI 00850001011082
FJK
Prescription
1
510(k) clearances
8,114
Adverse events (307 deaths)
36
Recalls
63
Facilities
Description
Tablo Cartridge with Needleless Infusion Ports Type B
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-29 | Fresenius Medical Care Renal Therapies Group, LLC | Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2026-03-19 | B Braun Medical Inc | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. |
| 2025-09-30 | B BRAUN MEDICAL INC | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors. |
| 2024-08-15 | B Braun Medical Inc | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rins |
| 2024-08-15 | B Braun Medical Inc | Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rin |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.