Health product recall

Teleflex Stylet, Endotracheal Kit and Flexi-Set

Last updated

Summary

Product
Teleflex Stylet, Endotracheal Kit and Flexi-Set
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Slick Set Stylet - Uncuffed KME21D1430 KME21E1290 KME21E1287 KME21E1232 KME21E1296 170080 170090 170085 170070
Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff KME21E0660 KME21E0021 KME21E0607 KME21E0002 KME21F1006 KME21D2020 KME21D2929 KME21E0288 KME21F0981 KME21F0946 KME21F0741 KME21D1946 KME21E0498 KME21F0930 112082055 112082060 112082070 112082065 112082075 112082080 112082085
Flexi-Set KME21E1286 504580

Issue

Teleflex has initiated a voluntary field safety corrective action due to reports of pilot balloon non-inflation or cuff non-deflation. In the event of pilot balloon non-inflation, there is a potential risk of injury to the patient as the pilot balloon no longer reflects the condition of the cuff, which may lead to over-inflation of the cuff. The risk persists in situ, therefore clinicians should evaluate the risk benefit to individual patients of extubation and reintubation. In the event of cuff non-deflation, there is the potential risk of injury if the device is removed from the patient with the cuff still inflated. If extubation and removal of the endotracheal tube is planned and the cuff cannot be deflated via the bespak valve, then the inflation line should be cut in order to facilitate passive deflation of the cuff.

Recall start date: December 9, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Teleflex Medical Sdn. Bhd.

Lot Pt 2577, Kamunting Perak, Malaysia, 34600

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-72404