The Recall Desk
HighFDA (Devices)·Z-0901-2017·Announced 2017-01-04

Medtronic NIM EMG Endotracheal Tubes Recalled for Exposed Wire Hazard

Medtronic Xomed is recalling NIM EMG Endotracheal Tubes because wire in the tubing can become exposed, posing potential harm to intubated patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm to patients (exposed wire) but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Xomed, Inc. is recalling NIM EMG Endotracheal Tubes, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. The recall involves 3,752 units of the product.

The recall is being conducted because wire in the tubing can become exposed, which poses potential harm to the intubated patient. The affected lots were distributed worldwide since May 2012, including in the United States, Puerto Rico, US Virgin Islands, and numerous international countries.

Healthcare providers and facilities should stop using the affected endotracheal tubes and contact Medtronic Xomed for instructions on how to return or dispose of the product.

The recalled product

Product
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Affected units
3,752

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 82-29307
  • & 82-29308
  • Catalog Ref No. (reinforced standard tubes
  • Japan) 8229306J
  • 8229307J
  • & 8229308J
  • Catalot Ref No. (reinforced contact tubes) 8229506
  • 8229507
  • & 8229508

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: