FDA Recall
Open, Classified
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Recall: Z-0696-2025
·
Initiated November 18, 2024
Recall
- Recall Number
- Z-0696-2025
- Event Number
- 95821
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- CBH
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 18, 2024
- Posted
- December 18, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
Reason
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
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 [email protected].
Distribution
US and Canada
Quantity
360 uinits