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Bubble Sensor (Maquet) – UDI Identifier Problem (2023)

The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

Low

FDADec 28, 2023AZ, CA, CO +10 more• Maquet Medical Systems USA

Monoject Syringe 20mL (Cardinal Health) – Product Correction (2023)

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

High

FDADec 28, 2023Nationwide• Cardinal Health 200, LLC

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Bubble Sensor (Maquet) – UDI Identifier Problem (2023)

Monoject Syringe 20mL (Cardinal Health) – Product Correction (2023)

AQUABILITI AQUASTAT (MRP) – sodium chloride issues (2023)

Cardinal Health Monoject (Cardinal Health) – product correction (2023)

Monoject Syringe 3mL (Cardinal Health) – Product Correction (2023)

Cardinal Health Monoject (Cardinal Health) – compatibility issues (2023)

Samsung Digital X-ray System (NeuroLogica) – Arm Welding Safety Issue (2023)

Monoject Tuberculin Syringe (Cardinal Health) – Product Correction (2023)

Monoject Enteral Syringe 60mL (Cardinal Health) – Compatibility Issue (2023)

Monoject Syringe 12mL (Cardinal Health) – Product Correction (2023)

Monoject Enteral Syringe 6mL (Cardinal Health) – Compatibility Issue (2023)

Monoject Syringe 35mL (Cardinal Health) – Product Correction (2023)

TruScan Body (TruAbutment) – scanning accuracy problems (2023)

Impella Catheters (Abiomed) – myocardial wall risk (2023)

Impella Catheters (Abiomed) – fiber contamination risk (2023)

GE Lullaby Incubator (GE Healthcare) – bedside panel issue (2023)

GE Neonatal Incubator (GE Healthcare) – bedside panel problem (2023)

GE Care Plus Hood (GE Healthcare) – bedside panel issue (2023)

Power Knee (Ossur) – battery failure risk (2023)

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)