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Halo pks cutting forceps

Official notice

1 Feb 2024

HighHealth Canada

An official Health Canada notice concerns Halo pks cutting forceps. Olympus has received eighteen (18) complaints for this issue, and sixteen (16) of these complaints were reported as serious injuries. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Through our investigation, Olympus has determined that the issue impacts lots manufactured between March 2022 to December 2023. Recall Start Date: January 19, 2024 Published 2024-02-01.

What to do now

Olympus canada inc. To recall.canada@olympus.com

Recall number

74987

Official notice

2024-02-01

The hazard

Olympus has received eighteen (18) complaints for this issue, and sixteen (16) of these complaints were reported as serious injuries. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Through our investigation, Olympus has determined that the issue impacts lots manufactured between March 2022 to December 2023. Recall Start Date: January 19, 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

74987

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Affected products

Product 1

Affected Products - HALO PKS Cutting Forceps, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - PK-CF0533

Risk / hazard

Olympus has received eighteen (18) complaints for this issue, and sixteen (16) of these complaints were reported as serious injuries. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Through our investigation, Olympus has determined that the issue impacts lots manufactured between March 2022 to December 2023. Recall Start Date: January 19, 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, Halo Pks Cutting Forceps.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

high

Recall details

Recall number

74987

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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