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B105P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

AQUACEL Foam Ag Adhesive (ConvaTec) – Visual Contamination (2022)

ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.

Low

FDANov 15, 2022Nationwide• ConvaTec, Inc

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B105P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

AQUACEL Foam Ag Adhesive (ConvaTec) – Visual Contamination (2022)

iTotal Identity Impactor Handle (Conformis) – Screw Loosening (2022)

Omnipod 5 Insulin System (Unknown) – Charging Port Melting (2022)

Power-PRO 2 (Stryker) – Cot Motion Risk (2022)

Abbott Alinity m System (Abbott) – Detection Unit Error (2022)

Vivid S6 N Ultrasound (GE Medical) – Battery Failure (2022)

Vivid i Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S5 N Ultrasound (GE Medical) – Battery Failure (2022)

Vivid S5 Ultrasound (GE Medical) – Battery Failure (2022)

Vivid q Ultrasound (GE Medical) – Battery Failure (2022)

X-CORE 2 Ti Core (NuVasive) – Implant Disengagement (2022)

Vivid S6 Ultrasound (GE Medical) – Battery Failure (2022)

Vivid q N Ultrasound (GE Medical) – Battery Failure (2022)

Vivid i N Ultrasound (GE Medical) – Battery Failure (2022)

VIDAS Clinical Rubella IGG (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Meropenem/Vaborbactam (Biomerieux) – Temperature Deviation (2022)

ETEST Clinical Ceftazidim/Avibactam (Biomerieux) – Temperature Deviation (2022)

PREVI Color Gram Cleaning Solution (Biomerieux) – Temperature Deviation (2022)

VITEK 2 Reagent AST-GP75 (Biomerieux) – Temperature Deviation (2022)