Z-0901-2017Class II

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

Name: Z-0901-2017 NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually...
Creator: Medtronic Xomed, Inc.
Published: 2016-06-28
License: https://open.fda.gov/license/

Medtronic Xomed, Inc. / initiated 2016-06-28 / Terminated

FDA source

Medtronic Xomed, Inc. began a recall of NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged on 2016-06-28. FDA classified it as Class II and gives the reason as "Wire in tubing can become exposed, posing potential harm to the intubated patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0901-2017
Classification: Class II
Status: Terminated
Initiated: 2016-06-28
Posted: 2016-12-23
Terminated: 2019-08-07
Recalling firm: Medtronic Xomed, Inc.
Product: NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Product code: ETN Stimulator, Nerve
Reason for recall: Wire in tubing can become exposed, posing potential harm to the intubated patient.
FDA root cause: Use error
Action: Medtronic sent an Urgent Product Safety Advisory letter dated June 28, 2016, to all affected customers informing them of the correction and providing instruction to avoid causing injury when using the EMG Endotracheal Tube. Recommended Actions included: inspecting the product thoroughly before use, testing the cuff by inflating it then deflating it before intubation, using a non-malleable stylet that closely matches the natural curve of the tube, not bending and flexing the tube excessively before use, and lubricating the cuff with a non-paralyzing, aqueous lubricant and a lubricated stylet. If customers found an EMG tube that appeared to have an electrode wire protruding from the distal end, the tube is not to be used and practitioners are urged to call Medtronic Product Quality Experience Department at 1-866-849-4003. For further questions , please call (904) 296-9600.
Quantity in commerce: 3752
Distribution: Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
Product codes and lots: All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0901-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0901-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-04	2016-12-23

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)