Z-0310-05

Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube...

Name: Z-0310-05 Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube...
Creator: Medtronic Xomed, Inc.
Published: 2004-10-29
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2004-10-29 / Terminated

FDA source

Medtronic Xomed, Inc. began a recall of 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... on 2004-10-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0310-05
Status: Terminated
Initiated: 2004-10-29
Posted: 2004-12-15
Terminated: 2012-07-07
Recalling firm: Medtronic Xomed, Inc.
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.]
Product code: ETN Stimulator, Nerve
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 root cause: Other
Quantity in commerce: 22569 EMG Tubes
Distribution: Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
Product codes and lots: Product Code: 77 ETN Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400

Product code ETN

K925640Class IIXomed-Treace EMG Endotracheal TubeenXomed-Treace, Inc. / cleared 1993-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)