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Jackson-Pratt Channel Drain (Cardinal Health) – Performance Issues (2022)

Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

Low

FDADec 14, 2022Nationwide• Cardinal Health 200, LLC

SPiN Thoracic Navigation System (Olympus) – Imaging Quality (2022)

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

Moderate

FDADec 13, 2022FL, GA, IN +8 more• Olympus Corporation of the Americas

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Jackson-Pratt Channel Drain (Cardinal Health) – Performance Issues (2022)

SPiN Thoracic Navigation System (Olympus) – Imaging Quality (2022)

Organ Recovery Pack (DeRoyal) – Suture Issue (2022)

Affinity Fusion Oxygenator (Medtronic) – Temperature Adapter (2022)

BD Pyxis MedBank System (CareFusion) – Medication Loading (2022)

Perfusion Tubing Packs (Medtronic) – Temperature Adapter (2022)

Epoc Host 2 (Siemens) – Quality Control Pressure (2022)

VERIFY Biological Indicators (Steris) – Growth Inconsistency (2022)

VERIFY Steam Test Pack (Steris) – Growth Inconsistency (2022)

Cobas Infinity Central Lab (Roche) – Order Rejection Issue (2022)

AXIOM Luminos Agile (Siemens) – Footrest Detachment (2022)

Alinity m System (Abbott) – Potential System Issues (2022)

Luminos Max Systems (Siemens) – Footrest Detachment (2022)

AXIOM Luminos Systems (Siemens) – Footrest Detachment (2022)

CADD Administration Set (Smiths Medical) – Delivery Issues (2022)

Flexi-Set Endotracheal Tube (Teleflex) – Cuff Inflation Issue (2022)

Slick Set Endotracheal Tube (Teleflex) – Cuff Inflation Issue (2022)

Detect Covid-19 Test (Detect) – False Negative Risk (2022)

RadiaLux Lighted Retractor (Medtronic) – Sterile Seal Defect (2022)

Adult Craniotome Attachment (Anspach) – Ball Bearing Failure (2022)