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Belmont 3-Spike Disposable Set (Belmont) – Connector Leak (2025)

Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

Moderate

FDAJan 2, 2025Nationwide• Belmont Instrument LLC

Access PCT Reagent Pack (Beckman) – Calibration Failure (2025)

Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.

Moderate

FDAJan 2, 2025Nationwide• Beckman Coulter Inc.

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Belmont 3-Spike Disposable Set (Belmont) – Connector Leak (2025)

Access PCT Reagent Pack (Beckman) – Calibration Failure (2025)

Brasseler ESR Endodontic File (US Endodontics) – Radiation Exposure (2025)

Socrates 38 Catheter (Scientia) – Packaging Breach (2025)

ARTIS One X-Ray System (Siemens) – First Release Issue (2025)

Novation XLE (Exactech) – Barrier Layer Missing (2024)

Medline Surgery Tray (Medline) – Catheter Hub Defect (2024)

AcuMatch XLE (Exactech) – Barrier Layer Missing (2024)

Alteon XLE (Exactech) – Barrier Layer Missing (2024)

NeiMed NasoGel (Neilmed) – Spray Stability Failure (2024)

Regard Newborn Kit (ROi CPS) – Pressure Loss Risk (2024)

VDR4 Phasitron Breathing Circuit (Percussionaire) – Venturi Component Stuck (2024)

Lev5 Susceptibility Discs (Oxoid) – Mislabeling Risk (2024)

AnchorFast SlimFit Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Centurion Infusion Catheter (Medline) – Mislabeling (2024)

AnchorFast Oral Endotracheal Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

AnchorFast Guard Select Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Medline Arterial Line Pack (Medline) – Mislabeling (2024)

AnchorFast Guard Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Continu-Flo Solution Set (Baxter) – Inverted Side Clamps (2024)