Health product recall

Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, and Thermovent™ 1200

Last updated

Summary

Product
Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, and Thermovent™ 1200
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Connector Double Swivel

4138707
4107293

100/255/150

Airway Nasopharyngeal 6.0mm 10/Bx

4133226

100/210/060

Airway Nasopharyngeal 8.0mm 10/Bx

4147168

100/210/080

Thermovent 1200-15mm/22mm Conn HME + 20/Ca

4119729
4135056

100/582/000

Portex 'Orator' Speaking Valve For Tracheostomy

4097683
4100700
4150794
4107294
413840
413841

100/550/000

Airway Nasopharyngeal 9.00mm 10/Bx

4088205

100/210/090

Issue

Smiths Medical has identified a timeframe where there is uncertainty in the seal integrity of the sterile packaging of the affected products. The potential risk of the uncertainty in the seal integrity of the sterile packaging is that a product labeled as sterile, may not be sterile, which could potentially lead to infection.

Recall Start Date: July 24, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - General hospital and personal use
Companies

Smiths Medical Asd, Inc.

6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75982

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