Heat And Moisture Exchanger (HME) And Filters
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
Teleflex Medical Sdn. Bhd.
Lot Pt 2577, Kamunting Perak, Malaysia, 34600
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