Z-0695-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2024
- Initiation Date
- November 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1332 units
Product Description
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
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 Pattern
US and Canada
Code Information
UDI/DI 20193489005308, (case), 10193489005301 (each); All Lots