The 4th Science Committee (parent committee) Meeting was Held
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Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.
May substantially increase blood pressure and/or pulse rate as well as present significant other health risks for patients.
Aidapak Services LLC, Specific Unit Dose Repackaged Products: Recall - Potential Incorrect Labeling
The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.
Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.
Increased risk of over-infusion or under-infusion if the infusion is started with the incorrect rate. This can cause serious adverse health consequences, including death.
Bacterial infections have been potentially associated with contaminated calcium gluconate infusions.
The company is making corrections and improvements to the device labeling to minimize likelihood of implanting the filter backwards.
Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.
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