HUDSON RCI mBrace recall
HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
Why was HUDSON RCI mBrace 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 20193489005308, (case), 10193489005301 (each); All Lots
- Product
- HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1332 units
- Distribution
- US and Canada
- Recall date
- December 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)