Z-0695-2025 Class II Ongoing
FDA device recall Z-0695-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Nov 18, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1332 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 25, 2024
- Initiation Date
- Nov 18, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0695-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026