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Sterilizable internal defibrillation paddles

Official notice

3 Oct 2024

MediumHealth Canada

An official Health Canada notice concerns Sterilizable internal defibrillation paddles. Stryker has received complaints indicating issues with the internal paddles. Complaints which state that the paddles are not reaching the expected cleaning and sterilization cycle count designated in the instructions for use and are showing signs of cracking. A CAPA was opened November 2023. Recall start date: September 20, 2024 Published 2024-10-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76244

Official notice

2024-10-03

The hazard

Stryker has received complaints indicating issues with the internal paddles. Complaints which state that the paddles are not reaching the expected cleaning and sterilization cycle count designated in the instructions for use and are showing signs of cracking. A CAPA was opened November 2023. Recall start date: September 20, 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

76244

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Affected products

Product 1

Affected products - Sterilizable Internal Defibrillation Paddles, Lot or serial number - 99649025, Model or catalogue number - 11131-000044

Product 2

Affected products - Sterilizable Internal Defibrillation Paddles, Lot or serial number - 107124605 101506304, Model or catalogue number - 11131-000043 11131-000046

Risk / hazard

Stryker has received complaints indicating issues with the internal paddles. Complaints which state that the paddles are not reaching the expected cleaning and sterilization cycle count designated in the instructions for use and are showing signs of cracking. A CAPA was opened November 2023. Recall start date: September 20, 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: Physio-control, Sterilizable Internal Defibrillation Paddles.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76244

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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