Device product
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Z-0695-2025
Product summary
- Event
- Event 95821
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1332 units
- Official record key
device-enforcement:Z-0695-2025
Official wording
Reason: 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.
Code information: UDI/DI 20193489005308, (case), 10193489005301 (each); All Lots
Distribution pattern: US and Canada
Derived failure modes
-
Unknown
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.