Health product recall

Heat And Moisture Exchanger (HME) And Filters

Last updated

Summary

Product
Heat And Moisture Exchanger (HME) And Filters
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Heat And Moisture Exchanger (HME) And Filters

KMZ21K0182

N/A

Issue

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

Additional information

Details
Original published date: 2022-09-23
Alert / recall type
Health product recall
Category
Health product - Medical device - Anaesthesiology
Companies

Teleflex Medical Sdn. Bhd.

Lot Pt 2577, Kamunting Perak, Malaysia, 34600

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64559