Public recall detail

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

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Recall Safety notice
Quick summary

Quick summary: Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandMedtronic Xomed Inc.
ProductNim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube
IssueMedical devices - Revised instructions for use
Recall classType I
IdentificationRA-64158

Affected products

ProductNim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube
LotMore than 10 numbers, contact manufacturer.
Model8229308, 8229506, 8229507, 8229508, 8229307, 8229306
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Ear, nose and throat
CompaniesMedtronic Xomed Inc. 6743 Southpoint Drive North, Jacksonville, Florida United States, 32216
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-64158
Background{}
CompaniesMedtronic Xomed Inc. 6743 Southpoint Drive North, Jacksonville, Florida United States, 32216
AudiencesGeneral public Health professionals Hospitals
Source updated2022-05-10

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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