Recall Z-0697-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated November 18, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
Codes / lots: UDI/DI 20193489005322 (case), 10193489005325 (each); All Lots
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0697-2025
- Initiated
- November 18, 2024
- Posted by FDA
- December 18, 2024
- Product code
- CBH – Device, Fixation, Tracheal Tube
- Quantity
- 1464 units
- Distribution
- US and Canada
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0695-2025 Class II | HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | 11/18/2024Open, Classified |
| Z-0696-2025 Class II | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | 11/18/2024Open, Classified |
| Z-0698-2025 Class II | HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF…Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder… | 11/18/2024Open, Classified |