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Duralife® autoclavable silicone extension tube

Official notice

14 Apr 2023

Last checked

14 Apr 2023

Medium riskHealth Canada

An official Health Canada notice concerns Duralife® autoclavable silicone extension tube. Smiths Medical has identified that the Duralife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the Duralife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient. Recall start date: March 30, 2023 Published 2023-04-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73516

Official notice

2023-04-14

The hazard

Smiths Medical has identified that the Duralife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the Duralife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient. Recall start date: March 30, 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

73516

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Affected products

Product 1

Affected products - Duralife® Autoclavable Silicone Extension Tube, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 60-1502 60-1510

Risk / hazard

Smiths Medical has identified that the Duralife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the Duralife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient. Recall start date: March 30, 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, Duralife® Autoclavable Silicone Extension Tube.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73516

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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