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Everest cutting forceps

Official notice

18 Sept 2024

CriticalHealth Canada

An official Health Canada notice concerns Everest cutting forceps. Olympus has received 15 complaints during the December 2018 - December 2023 timeframe from customers indicating fractures and breakages in packaging trays and Tyvek covers which may lead to a sterility breach. The root cause of the broken trays is related to a packaging change. Olympus has received no reports of adverse events related to the identified issue. Recall Start Date: July 2, 2024 Published 2024-09-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76047

Official notice

2024-09-18

The hazard

Olympus has received 15 complaints during the December 2018 - December 2023 timeframe from customers indicating fractures and breakages in packaging trays and Tyvek covers which may lead to a sterility breach. The root cause of the broken trays is related to a packaging change. Olympus has received no reports of adverse events related to the identified issue. Recall Start Date: July 2, 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

76047

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Affected products

Product 1

Affected products - Everest Cutting Forceps, Lot or serial number - FR204443 FR176934 FR246906 FR305512 FR215026 FR141534 FR165250, Model or catalog number - 3005

Risk / hazard

Olympus has received 15 complaints during the December 2018 - December 2023 timeframe from customers indicating fractures and breakages in packaging trays and Tyvek covers which may lead to a sterility breach. The root cause of the broken trays is related to a packaging change. Olympus has received no reports of adverse events related to the identified issue. Recall Start Date: July 2, 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: Gyrus Acmi, Everest Cutting Forceps.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

76047

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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