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Disposable rotatable clip fixing device

Official notice

17 Mar 2023

Last checked

17 Mar 2023

Medium riskHealth Canada

An official Health Canada notice concerns Disposable rotatable clip fixing device. Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. Investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment, prolonged episode of care, and unexpected medical intervention are the potential harms associated with clip nondeployment. Recall start date: February 23. 2023 Published 2023-03-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73339

Official notice

2023-03-17

The hazard

Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. Investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment, prolonged episode of care, and unexpected medical intervention are the potential harms associated with clip nondeployment. Recall start date: February 23. 2023

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

73339

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Affected products

Product 1

Affected products - Disposable Rotatable Clip Fixing Device, Lot or serial number - Contact the manufacturer., Model or catalog number - HX-201LR-135 HX-201UR-135

Risk / hazard

Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. Investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment, prolonged episode of care, and unexpected medical intervention are the potential harms associated with clip nondeployment. Recall start date: February 23. 2023

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: Olympus Medical, Disposable Rotatable Clip Fixing Device.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73339

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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