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Karl storz telescopes

Official notice

27 Aug 2024

Last checked

27 Aug 2024

Medium riskHealth Canada

An official Health Canada notice concerns Karl storz telescopes. The IFUs for the devices identifiers previously included cleaning methods other than manual cleaning and pre-vacuum steam as the approved reprocessing modalities. The IFU was updated to only include these two methods moving forward; therefore, there is a risk that a reprocessing modality that is not currently cleared could be utilized for reprocessing these devices. Recall start date: July 25, 2024 Published 2024-08-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75889

Official notice

2024-08-27

The hazard

The IFUs for the devices identifiers previously included cleaning methods other than manual cleaning and pre-vacuum steam as the approved reprocessing modalities. The IFU was updated to only include these two methods moving forward; therefore, there is a risk that a reprocessing modality that is not currently cleared could be utilized for reprocessing these devices. Recall start date: July 25, 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

75889

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Affected products

Product 1

Affected prodcuts - Telescopes, Lot or serial number - All lots., Model or catalogue number - 27830KA 27840KA

Product 2

Affected prodcuts - Hopkins Telescope, Lot or serial number - All lots., Model or catalogue number - 27093AA 27292AMA 27293AA 27092AMA

Product 3

Affected prodcuts - Nephro/Chold, Berci Telescope, Lot or serial number - All lots., Model or catalogue number - 27295AA 27294AA

Risk / hazard

The IFUs for the devices identifiers previously included cleaning methods other than manual cleaning and pre-vacuum steam as the approved reprocessing modalities. The IFU was updated to only include these two methods moving forward; therefore, there is a risk that a reprocessing modality that is not currently cleared could be utilized for reprocessing these devices. Recall start date: July 25, 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, Karl Storz Telescopes.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75889

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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