Class 2 Device Recall

• Date Initiated by Firm: October 29, 2004
• Date Posted: December 15, 2004
• Recall Status: Terminated on July 07, 2012
• Recall Number: Z-0310-05
• Recall Event ID: 30357
• 510(K)Number: K925640
• Product Classification: Stimulator, Nerve - Product Code ETN
• Product: Brand name: ; NIM¿ EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108; ; NIM¿ EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308; ; [All products are packaged one unit per box.]
• Code Information: Product Code: 77 ETN Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400
• Recalling Firm/ Manufacturer: Medtronic Xomed, Inc.; 6743 Southpoint Dr N; Jacksonville FL 32216-6218
• Manufacturer Reason for Recall: The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
• FDA Determined Cause: Other
• Quantity in Commerce: 22569 EMG Tubes
• Distribution: Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ETN and Original Applicant = XOMED-TREACE, INC.