Recall Z-1012-2023— TELEFLEX LLC
Class II · Ongoing
Class II FDA medical device recall by TELEFLEX LLC, initiated 2022-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation. Reason: Potential for pilot balloon non-inflation or cuff non-deflation..
- Recalling firm
- TELEFLEX LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-08
- Firm location
- Morrisville, NC, United States
Product description
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
Reason for recall
Potential for pilot balloon non-inflation or cuff non-deflation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.