Recall Z-0901-2017— Medtronic Xomed, Inc.

Name: FDA recall Z-0901-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-28

Class II · Terminated

Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2016-06-28, terminated 2019-08-07. It names one FDA 510(k) clearance: K925640. Product: NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.. Reason: Wire in tubing can become exposed, posing potential harm to the intubated patient..

Recalling firm: Medtronic Xomed, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-28
Terminated: 2019-08-07
Firm location: Jacksonville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K925640 — XOMED-TREACE EMG ENDOTRACHEAL TUBEENXomed-Treace, Inc.·cleared 1993-08-17

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 EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.

Reason for recall

Wire in tubing can become exposed, posing potential harm to the intubated patient.

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