Health product recall

Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube

Last updated

Summary

Product
Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube

More than 10 numbers, contact manufacturer.

8229308, 8229506, 8229507, 8229508, 8229307, 8229306

Issue

Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend, herniate, or distort over the end of the tube and/or the murphy-eye causing obstruction of the patient's airway and loss of ventilation.

Manufacturer is notifying customers to carefully review and adhere to the instructions for use (IFU). Manufacturer is also providing additional recommendations on steps to follow when encountering obstruction.

Recall start date: Apr 29, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies

Medtronic Xomed Inc.

6743 Southpoint Drive North, Jacksonville, Florida

United States, 32216

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-64158

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