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Adapters may be occluded potentially preventing inhalation
Risk of hubs becoming disconnected from the cannula.
Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leask past and may cause an inaccurate infusion rate..
Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.
Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
decrease in product stability after reconstitution and reduced stability on board certain instrument systems
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
The elastic bandages which are labeled sterile have a lack of assurance of sterility.
The instrument power cord may become disconnected from the instrument and pose a fire or electrical shock hazard.