No image published for this recall

No image published for this recall

Bivona pediatric tracheostomy tube

Official notice

31 Aug 2023

Last checked

31 Aug 2023

Medium riskHealth Canada

An official Health Canada notice concerns Bivona pediatric tracheostomy tube. Smiths Medical has identified that the manufacturing date was incorrectly included as the expiration date on the unit box. The actual individual packaging has the correct expiration date which is march 17, 2026. The identified incorrect expiration date on the unit box presents the potential for a customer to assess the product as expired, resulting in the potential for a delay in the availability to use the tracheostomy device. Recall start date: August 16, 2023 Published 2023-08-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74219

Official notice

2023-08-31

The hazard

Smiths Medical has identified that the manufacturing date was incorrectly included as the expiration date on the unit box. The actual individual packaging has the correct expiration date which is march 17, 2026. The identified incorrect expiration date on the unit box presents the potential for a customer to assess the product as expired, resulting in the potential for a delay in the availability to use the tracheostomy device. Recall start date: August 16, 2023

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

74219

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Affected products

Product 1

Affected products - Bivona Pediatric Tracheostomy Tube, Lot or serial number - 4125816, Model or catalogue number - 60P045

Risk / hazard

Smiths Medical has identified that the manufacturing date was incorrectly included as the expiration date on the unit box. The actual individual packaging has the correct expiration date which is march 17, 2026. The identified incorrect expiration date on the unit box presents the potential for a customer to assess the product as expired, resulting in the potential for a delay in the availability to use the tracheostomy device. Recall start date: August 16, 2023

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

Manufacturer

Not provided

Phone

Not provided

Brand: Smiths Medical Asd, Bivona Pediatric Tracheostomy Tube.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74219

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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