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Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Product contains undeclared milk and soy.
Small pieces of plastic broken tray in the product.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Due to nasal spray stability failure for bioburden.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Milk not listed in the ingredients or included in parentheses after American Cheese.
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.