FDA (Devices) recall action 95821
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.
Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.
Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.
Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace tracheal tube holder due to adhesive and frame defects that may cause skin pressure injury. The device defect puts pressure on patients' cheekbones and upper lip depending on positioning.