FDA-Device2024-12-25Class II
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
US and Canada
Affected count
768 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0698-2025Don't want to check this manually?
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