HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
This recall is currently active, issued December 18, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 18, 2024
- Posted
- December 18, 2024
- Recall Number
- Z-0696-2025
- Quantity
- 360 uinits
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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
US and Canada
Lot / Code Info
UDI/DI 20193489005315 (case), 10193489005318 (each); All Lots
Root 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.