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Heat and moisture exchanger (hme) and filters

Official notice

20 Sept 2022

Last checked

20 Sept 2022

Medium riskHealth Canada

An official Health Canada notice concerns Heat and moisture exchanger (hme) and filters. Teleflex is initiating this voluntary recall for the above-mentioned products due to reports of the device splitting or detaching during use. The devices are intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation. As of August 2022, a total of 36 complaints reporting the filter splitting or detaching have been received for the products in scope of this recall. Of these 36 complaints, 4 complaints reported injuries including desaturation. No deaths or long-term patient injuries have been reported at this time. Recall start date: August 29, 2022 Published 2022-09-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64559

Official notice

2022-09-20

The hazard

Teleflex is initiating this voluntary recall for the above-mentioned products due to reports of the device splitting or detaching during use. The devices are intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation. As of August 2022, a total of 36 complaints reporting the filter splitting or detaching have been received for the products in scope of this recall. Of these 36 complaints, 4 complaints reported injuries including desaturation. No deaths or long-term patient injuries have been reported at this time. Recall start date: August 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

64559

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Affected products

Product 1

Affected products - Heat And Moisture Exchanger (HME) And Filters, Lot or serial number - KMZ21K0182, Model or catalogue number - N/A

Risk / hazard

Teleflex is initiating this voluntary recall for the above-mentioned products due to reports of the device splitting or detaching during use. The devices are intended for connection to respiratory equipment in intensive care units and operating theatres to protect the equipment from potential airborne contaminants. If the filter splits or detaches during use, the functionality and efficiency of the device may be compromised, potentially resulting in a leakage and insufficient air supply to the patient with potential desaturation. As of August 2022, a total of 36 complaints reporting the filter splitting or detaching have been received for the products in scope of this recall. Of these 36 complaints, 4 complaints reported injuries including desaturation. No deaths or long-term patient injuries have been reported at this time. Recall start date: August 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

Manufacturer

Not provided

Phone

Not provided

Brand: Teleflex Medical, Heat And Moisture Exchanger And Filters.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64559

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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