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Approach cto-6 and hydro st microwire guide with hydrophylic coating

Official notice

10 Oct 2024

Last checked

10 Oct 2024

Medium riskHealth Canada
Watch Cook

An official Health Canada notice concerns Approach cto-6 and hydro st microwire guide with hydrophylic coating. Devices from the affected device lots have labels that state the incorrect expiration dates. Preliminary investigation into this issue identified a calculation error occurred in Cook's labeling software, which uses a calculator to determine the correct expiration date. Due to this error, the calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life. Recall Start Date: October 8, 2024 Published 2024-10-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76312

Official notice

2024-10-10

The hazard

Devices from the affected device lots have labels that state the incorrect expiration dates. Preliminary investigation into this issue identified a calculation error occurred in Cook's labeling software, which uses a calculator to determine the correct expiration date. Due to this error, the calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life. Recall Start Date: October 8, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

76312

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Affected products

Product 1

Affected products - Approach Hydro ST Microwire Guide With Hydrophylic Coating, Lot or serial number - 15894225 15858389 15863267 15765951 15894224, Model or catalog number - HMW-14-190-ST HMW-14-300-ST

Product 2

Affected products - Approach CTO-6 Microwire Guide, Lot or serial number - 15835853 15885579 15718980 15891910 15891906 15802931 15835856 15802931X 15794896 15863270 15892397, Model or catalog number - CMW-14-300-18G CMW-14-300-25G CMW-14-190-18G

Risk / hazard

Devices from the affected device lots have labels that state the incorrect expiration dates. Preliminary investigation into this issue identified a calculation error occurred in Cook's labeling software, which uses a calculator to determine the correct expiration date. Due to this error, the calculator assigned the maximum potential shelf life to lots in scope rather than the actual shelf life. Recall Start Date: October 8, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Cook, Approach Cto-6 And Hydro St Microwire Guide With Hydrophylic Coating

Manufacturer

Not provided

Phone

Not provided

Brand: Cook, Approach Cto-6 And Hydro St Microwire Guide With Hydrophylic Coating.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76312

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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