Tracheal Tube Holder Recalled for Defect Causing Potential Skin Pressure Injury
Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace tracheal tube holder due to adhesive and frame defects that may cause skin pressure injury. The device defect puts pressure on patients' cheekbones and upper lip depending on 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 an FDA Class II medical device recall for a design defect in a patient care device. The defect has potential to cause dermal injury, but no reported injuries or hospitalizations have been documented. Per the severity rubric, a risk-of-harm product with no reported injury merits a High classification.
Plain-English summary
Medline Industries is recalling 1,464 units of the HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap (REF DYNJMBRC4), a medical device used to secure tracheal (endotracheal) tubes in patients requiring respiratory support. The device is distributed in the US and Canada.
The recall is due to defects in the adhesive elements and frame of the device. These components can place excessive pressure on the patient's cheekbones and upper lip, which may cause dermal (skin) injury depending on how the device is positioned.
Patients and healthcare providers who have been using this device should be aware of this potential risk and contact the manufacturer or their healthcare provider for guidance.
The recalled product
- Product
- HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- dermal-injury
- pressure-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 20193489005322 (case)
- 10193489005325 (each)
- All Lots
Distribution
Distribution scope not specified by the agency.
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