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