No image published for this recall

No image published for this recall

Nim™ standard reinforced emg endotracheal tube & nim contact™ reinforced emg endotracheal tube

Official notice

10 May 2022

Last checked

10 May 2022

High riskHealth Canada

An official Health Canada notice concerns Nim™ standard reinforced emg endotracheal tube & nim contact™ reinforced emg endotracheal tube. 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 Published 2022-05-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64158

Official notice

2022-05-10

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64158

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Affected products

Product 1

Affected Products - Nim™ Standard Reinforced Emg Endotracheal Tube & Nim Contact™ Reinforced Emg Endotracheal Tube, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 8229308, 8229506, 8229507, 8229508, 8229307, 8229306

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Medtronic Xomed, Nim™ Standard Reinforced Emg Endotracheal Tube Nim Contact™ Reinforced Emg Endotracheal Tube.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type I

App estimate

high

Recall details

Recall number

64158

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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