Class II
Medical Device Recall: HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield · November 18, 2024
Reason for Recall
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.
Distribution
US and Canada
Quantity Affected
768 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0698-2025
Status: ongoing
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