—#211291

Product

HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

FDA product code: CBH — Device, Fixation, Tracheal Tube
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: UDI/DI 20193489005322 (case), 10193489005325 (each); All Lots

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US and Canada

Timeline

Recall initiated: 2024-11-18
Posted by FDA: 2024-12-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.