B Braun Medical SESK Pain Management Tray Recall Affects 2,450 Units Nationwide (2025)
Potential for the lid of the catheter connector to be in the incorrect position.
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Potential for the lid of the catheter connector to be in the incorrect position.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Potential for the lid of the catheter connector to be in the incorrect position.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Potential for the lid of the catheter connector to be in the incorrect position.
CGMP Deviations: Market complaints received for gritty texture (grainy)
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.