Recall Z-0696-2025 ยท CBH Device, Fixation, Tracheal Tube
MEDLINE INDUSTRIES, LP - Northfield
HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device
| Date | Dec 18, 2024 (initiated Nov 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL to its consignees of 11/18/2024 via USPS and email. The notice explained the issue, risk to user, and requested the destruction of the affected product. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 360 uinits |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.