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8694 - Laser application instrument, 23 cm

Official notice

12 Jul 2024

Last checked

12 Jul 2024

Medium riskHealth Canada

An official Health Canada notice concerns 8694 - Laser application instrument, 23 cm. It was found that there is insufficient evidence to show that the reprocessing method of the products was adequately validated. This issue affects all lot numbers of the referenced Karl Storz article numbers. During the update of the technical documentation, it was determined that there is insufficient evidence of the validation of the reprocessing methods; therefore, the affected products are being recalled. Recall start date: March 1, 2024 Published 2024-07-12.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75810

Official notice

2024-07-12

The hazard

It was found that there is insufficient evidence to show that the reprocessing method of the products was adequately validated. This issue affects all lot numbers of the referenced Karl Storz article numbers. During the update of the technical documentation, it was determined that there is insufficient evidence of the validation of the reprocessing methods; therefore, the affected products are being recalled. 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

75810

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Affected products

Product 1

Affected products - 8694 - Laser Application Instrument, 23 Cm, Lot or serial number - All lots., Model or catalogue number - 461000

Risk / hazard

It was found that there is insufficient evidence to show that the reprocessing method of the products was adequately validated. This issue affects all lot numbers of the referenced Karl Storz article numbers. During the update of the technical documentation, it was determined that there is insufficient evidence of the validation of the reprocessing methods; therefore, the affected products are being recalled. 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: Karl Storz Se Kg, 8694 - Laser Application Instrument 23 Cm.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75810

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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