Recall Z-0743-2022— Medtronic Xomed, Inc.

Name: FDA recall Z-0743-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Class II · Ongoing

Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2021-12-22. It names one FDA 510(k) clearance: K112686. Product: NIM TRIVANTAGE EMG Endotracheal Tube. Reason: There is potential for multiple issues due to a manufacturing nonconformity..

Recalling firm: Medtronic Xomed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-12-22
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112686 — NEXT GEN EMG ENDOTRACHEAL TUBEMedtronic Xomed, Inc.·cleared 2012-06-27

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

NIM TRIVANTAGE EMG Endotracheal Tube

Reason for recall

There is potential for multiple issues due to a manufacturing nonconformity.

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