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Pediatric Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

High

FDAMay 29, 2024Nationwide• Smiths Medical ASD Inc.

CryoValve SG Pulmonary Heart Valve (Artivion) – Invalid Test Results (2024)

Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

Low

FDAMay 28, 2024Nationwide• Artivion, Inc

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Pediatric Tracheostomy Tube (Smiths Medical) – Flange Tear Risk (2024)

CryoValve SG Pulmonary Heart Valve (Artivion) – Invalid Test Results (2024)

CryoPatch SG Pulmonary Hemi-Artery (Artivion) – Invalid Test Results (2024)

PROBEAT-FR (Hitachi) – Image Matching Software Error (2024)

Beckman Coulter IGM Reagent (Beckman Coulter) – Lipemia Result Inaccuracy (2024)

Cue COVID-19 Test Cartridge (CUE HEALTH) – Unauthorized Distribution (2024)

WOM Tube Set (WOM) – Transponder Data Error (2024)

Gray Revision Instrument Tray (Howmedica) – Case Design Issue (2024)

Surgical Image Guidance (Alcon) – Software Movement Error (2024)

HRIS Storage Tray (Howmedica) – Case Design Problem (2024)

CentriMag Primary Console (Thoratec) – Power Standard Nonconformance (2024)

Endo Model M Tibial Components (Waldemar Link) – Surgical Screw Issue (2024)

Avalon Ultrasound Transducer (Philips) – Fetal Measurement Error (2024)

DxI 9000 Access Analyzer (Beckman Coulter) – Laboratory System Compatibility (2024)

Abbott Infinity 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Endo Model SL Tibial Components (Waldemar Link) – Surgical Screw Problem (2024)

Prelude Roadster Guide Sheath (Merit Medical) – Connection Risk (2024)

Abbott Infinity 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

Beckman Coulter DxI 9000 Analyzer (Beckman Coulter) – System Connectivity (2024)

BD Alaris System Manager (CareFusion) – Wireless Data Transmission (2024)