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There is potential for packaging defects that may impact the sterile barrier.
Sterility assurance may be compromised.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
The firm was notified during an inspection by the State that the product contains undeclared soy.
There is potential for false positive results.
Superpotent Drug
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.