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Roadrunner guidewire

Official notice

25 Jul 2022

MediumHealth Canada

An official Health Canada notice concerns Roadrunner guidewire. Cook Medical identified that samples from the affected device lots did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. This failure was traced to material that is supplied to Cook Medical from an external supplier. Recall start date: July 19, 2022 Published 2022-07-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64401

Official notice

2022-07-25

The hazard

Cook Medical identified that samples from the affected device lots did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. This failure was traced to material that is supplied to Cook Medical from an external supplier. Recall start date: July 19, 2022

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

64401

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Affected products

Product 1

Affected products - Roadrunner Pc Guidewire, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - RLPC-35-180 RFSPC-35-180

Risk / hazard

Cook Medical identified that samples from the affected device lots did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. This failure was traced to material that is supplied to Cook Medical from an external supplier. Recall start date: July 19, 2022

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: Cook, Roadrunner Guidewire.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64401

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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