Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Recall database
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Lack of Assurance of Sterility
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut)
Sesame Seeds White were labeled as Curry Powder Sweet.
Due to unsealed portions of pouches.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.



Due to out-of-specification, or potential out-of-specification, levels of endotoxins


