medical Class II Updated 2024-12-25

MEDLINE INDUSTRIES, LP - Northfield recalls HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, R

Recalled Product

HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device


Hazard / Issue

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.

Issued by

FDA

Distribution: US and Canada
Lot/Code Info: UDI/DI 20193489005322 (case), 10193489005325 (each); All Lots
View official government recall

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