Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Recall database
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
Reusable electrodes may not meet expected performance levels.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reusable electrodes may not meet expected performance levels.
Sterile anchors my lack sterility assurance.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.