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: 2022-12-22
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
Industry
Recall class
Type II
Identification number
RA-72404