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Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Undeclared Red 40
Undeclared allergens (milk).
Undeclared allergens (cashews).
Contains undeclared Red 40
Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1
Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6
The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
Storyteller Overland, LLC (Storyteller) is recalling certain 2024-2026 GXV Hilt recreational vehicles. The auxiliary power system wires may have been improperly. The wires may be damaged by contact with the intake manifold.
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Chrysler (FCA US, LLC) is recalling certain 2017-2019 Alfa Romeo Giulia and 2018-2019 Alfa Romeo Stelvio vehicles. The fuel pump may fail, which can result in a loss of fuel flow and loss of drive power.
Zero Motorcycles Inc. (Zero) is recalling certain 2023-2024 DSR/X, 2024 DS, DSR, and DSRP motorcycles. Improperly routed key switch signal wires may break, causing a loss of drive power.