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Regard CV PK (ROi CPS) – Chest Drain Issues (2023)

Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.

Moderate

FDASep 21, 2023MO• ROi CPS LLC

DigitalDiagnost 4 (Philips) – Ceiling Unit Failure Risk (2023)

Potential for units suspended on the ceiling to fail and fall.

High

FDASep 21, 2023Nationwide• Philips North America Llc

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Regard CV PK (ROi CPS) – Chest Drain Issues (2023)

DigitalDiagnost 4 (Philips) – Ceiling Unit Failure Risk (2023)

DigitalDiagnost 4 (Philips) – Ceiling Failure (2023)

ProxiDiagnost N90 (Philips) – Ceiling Unit Failure Risk (2023)

DigitalDiagnost 4 High Performance (Philips) – Ceiling Failure (2023)

Infusomat Large Volume Pump (B. Braun) – Occlusion Alarm (2023)

Advanta V12 Stent (Atrium) – Balloon Weld Failure (2023)

Monoject 1 mL Tuberculin Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 60 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 12 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 20 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 6 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 35 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Vasoview 6 Pro (Maquet) – Packaging Error (2023)

LeadCare II Test Kit (Magellan) – Plastic Cap Issue (2023)

NeuroSync EYE-SYNC (NeuroSync) – Syncing Problems (2023)

Head and Neck Procedure Kit (DeRoyal) – Syringe Recall (2023)

Oasis Dry Suction Chest Drains (Atrium) – Setup Instructions (2023)

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)

Ocean Water Seal Chest Drains (Atrium) – Setup Instructions (2023)