ET Tube Holder Recalled Due to Skin Pressure Defect Risk
Medline is recalling HUDSON RCI mBrace ET tube holders because defective adhesive and frame can cause pressure on patients' cheeks and lips, risking skin injury. The risk depends on device positioning.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall with no reported injuries or illnesses. The identified defect creates risk of dermal injury through mechanical pressure, but the hazard remains theoretical. Per FDA criteria, recalls with identified defects but without reported harm are classified as High severity at most.
Plain-English summary
Medline Industries, LP is recalling the HUDSON RCI mBrace ET Tube Holder with Bite Block and 4 Point Head Strap (Reference DYNJMBRC4B). The recall affects approximately 768 units distributed in the US and Canada.
The device contains defective adhesive elements and a frame that place additional pressure on the patient's cheekbones and upper lip. Depending on how the device is positioned, this pressure may cause dermal injury to the patient.
Patients and healthcare providers currently using this device should consult with their medical provider about continued use. Healthcare facilities should identify affected units using the provided UDI codes (case: 20193489005339; individual: 10193489005332) covering all lots.
The recalled product
- Product
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- pressure-injury
- dermal-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 20193489005339 (case)
- 10193489005332 (each)
- All Lots
Distribution
Distribution scope not specified by the agency.
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