HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
FDA device recall Z-0697-2025 · posted 2024-12-18 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Action taken
- Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignees of 11/18/2024 via USPS and email. The notice explained the issue, risk to user, and requested the destruction of the affected product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CBH
- Quantity affected
- 1464 units
- Distribution
- US and Canada
- Date initiated
- 2024-11-18
- Date posted
- 2024-12-18
- Location
- Northfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.