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Open, Classified

HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

FDA Recall Z-0697-2025 · Posted 2024-12-18

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeCBH
Date Initiated2024-11-18
Product Quantity1464 units

Reason for Recall

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.

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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