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Cook medical needles, peel-away® introducers, and dilators

Official notice

31 May 2024

MediumHealth Canada

An official Health Canada notice concerns Cook medical needles, peel-away® introducers, and dilators. Cook Medical identified that devices from the affected device lots may have packaging seals that do not meet peel strength specifications. This creates a potential of a sterile barrier failure that could result in compromised device sterility. Recall start date: March 1, 2024 Published 2024-05-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75601

Official notice

2024-05-31

The hazard

Cook Medical identified that devices from the affected device lots may have packaging seals that do not meet peel strength specifications. This creates a potential of a sterile barrier failure that could result in compromised device sterility. Recall start date: March 1, 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

75601

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Affected products

Product 1

Affected product - Peel-Away Introducer Sets And Trays, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - PLVW-XXX

Risk / hazard

Cook Medical identified that devices from the affected device lots may have packaging seals that do not meet peel strength specifications. This creates a potential of a sterile barrier failure that could result in compromised device sterility. Recall start date: March 1, 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

Manufacturer

Not provided

Phone

Not provided

Brand: Cook, Cook Medical Needles Peel-away® Introducers And Dilators.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75601

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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