No image published for this recall

No image published for this recall

Nasopharyngeal airway, double swivel connector, 15mm y piece, portex™ orator speaking valve, and thermovent™ 1200

Official notice

29 Aug 2024

Last checked

29 Aug 2024

Critical riskHealth Canada

An official Health Canada notice concerns Nasopharyngeal airway, double swivel connector, 15mm y piece, portex™ orator speaking valve, and thermovent™ 1200. 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 Published 2024-08-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75982

Official notice

2024-08-29

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

75982

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Affected products

Product 1

Affected products - Connector Double Swivel, Lot or serial number - 4138707 4107293, Model or catalog number - 100/255/150

Product 2

Affected products - Airway Nasopharyngeal 6.0mm 10/Bx, Lot or serial number - 4133226, Model or catalog number - 100/210/060

Product 3

Affected products - Airway Nasopharyngeal 8.0mm 10/Bx, Lot or serial number - 4147168, Model or catalog number - 100/210/080

Product 4

Affected products - Thermovent 1200-15mm/22mm Conn HME + 20/Ca, Lot or serial number - 4119729 4135056, Model or catalog number - 100/582/000

Product 5

Affected products - Portex 'Orator' Speaking Valve For Tracheostomy, Lot or serial number - 4097683 4100700 4150794 4107294 413840 413841, Model or catalog number - 100/550/000

Product 6

Affected products - Airway Nasopharyngeal 9.00mm 10/Bx, Lot or serial number - 4088205, Model or catalog number - 100/210/090

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Smiths Medical Asd, Nasopharyngeal Airway Double Swivel Connector 15mm Y Piece Portex™ Orator Speaking Valve And Thermovent™ 1200.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

75982

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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