HUDSON RCI mBrace ET Tube Holder Risks Facial Dermal Injury
Medline is recalling the HUDSON RCI mBrace ET tube holder because defective adhesive and frame elements may cause pressure and skin injury to the face.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device defect that poses a risk of dermal injury to patients. No injuries have been reported. Per the FDA rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Medline Industries is recalling the HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap (REF DYNJMBRC2), a medical device designed to secure endotracheal tubes. The recall involves 1,332 units distributed in the US and Canada.
The device has defective adhesive elements and frame that can put additional pressure on patients' cheekbones and upper lip. Depending on how the device is positioned, this pressure may cause dermal injury to the patient's skin.
Patients and healthcare providers using this device should contact Medline Industries for instructions on safe removal or replacement.
The recalled product
- Product
- HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,332
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 (4)
- UDI/DI 20193489005308
- (case)
- 10193489005301 (each)
- All Lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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Same hazard · dermal injury
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