Recall Z-1881-2023— TELEFLEX LLC

Name: FDA recall Z-1881-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Class I · Ongoing

Class I FDA medical device recall by TELEFLEX LLC, initiated 2023-05-25. It names one FDA 510(k) clearance: K961837. Product: Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055. Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products..

Recalling firm: TELEFLEX LLC
Classification: Class I
Status: Ongoing
Initiated: 2023-05-25
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 oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055

Reason for recall

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Data sourced from openFDA. This site is unofficial and independent of the FDA.