Recall Z-1011-2023— TELEFLEX LLC

Name: FDA recall Z-1011-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-08

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX LLC, initiated 2022-12-08. It names one FDA 510(k) clearance: K961837. Product: Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super 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

510(k) clearances named in this recall

1 on FDA's record

K961837 — RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYRusch Intl.·cleared 1996-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super 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.