ET Tube Holder Recalled for Risk of Facial Skin Injury
Medline's HUDSON RCI mBrace ET tube holder is being recalled because its adhesive and frame design may put excessive pressure on patients' cheekbones and upper lip, potentially causing skin injury.
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: FDA Class II device with potential for dermal injury from device-induced facial pressure. No illnesses or injuries have been reported; the hazard is theoretical depending on device positioning, placing this at the maximum threshold for unconfirmed harm to at-risk patients.
Plain-English summary
Medline Industries is recalling the HUDSON RCI mBrace, an endotracheal (ET) tube holder designed to secure breathing tubes in patients. The device is a tracheal tube fixation device with a bite block and two-point head strap.
The recall has been initiated because of defects in the adhesive elements and the frame of the holder. Depending on how the device is positioned, these defects can put additional pressure on the patient's cheekbones and upper lip, which may result in dermal (skin) injury.
The recall affects approximately 360 units that were distributed in the United States and Canada across all production lots. Patients or healthcare providers currently using this device should contact Medline Industries for guidance on next steps.
The recalled product
- Product
- HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; 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 20193489005315 (case)
- 10193489005318 (each)
- All Lots
Distribution
Distribution scope not specified by the agency.
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