Public recall detail

Teleflex Stylet, Endotracheal Kit and Flexi-Set

2022-12-22

medium
Recall Safety notice
Quick summary

Quick summary: Teleflex Stylet, Endotracheal Kit and Flexi-Set. Date: 2022-12-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Teleflex Stylet, Endotracheal Kit and Flexi-Set. Date: 2022-12-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandTeleflex Medical Sdn. Bhd.
ProductTeleflex Stylet, Endotracheal Kit and Flexi-Set
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72404

Affected products

ProductSlick Set Stylet - Uncuffed
LotKME21D1430 KME21E1290 KME21E1287 KME21E1232 KME21E1296
Model170080 170090 170085 170070
Serial numberKME21D1430 KME21E1290 KME21E1287 KME21E1232 KME21E1296
DescriptionSlick Set Stylet - Uncuffed
ProductEndotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff
LotKME21E0660 KME21E0021 KME21E0607 KME21E0002 KME21F1006 KME21D2020 KME21D2929 KME21E0288 KME21F0981 KME21F0946 KME21F0741 KME21D1946 KME21E0498 KME21F0930
Model112082055 112082060 112082070 112082065 112082075 112082080 112082085
Serial numberKME21E0660 KME21E0021 KME21E0607 KME21E0002 KME21F1006 KME21D2020 KME21D2929 KME21E0288 KME21F0981 KME21F0946 KME21F0741 KME21D1946 KME21E0498 KME21F0930
DescriptionEndotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff
ProductFlexi-Set
LotKME21E1286
Model504580
Serial numberKME21E1286
DescriptionFlexi-Set

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Anaesthesiology
CompaniesTeleflex Medical Sdn. Bhd. Lot Pt 2577, Kamunting Perak, Malaysia, 34600
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72404
Background{}
CompaniesTeleflex Medical Sdn. Bhd. Lot Pt 2577, Kamunting Perak, Malaysia, 34600
AudiencesHealthcare Industry
Source updated2022-12-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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