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Karl storz injection needles

Official notice

31 Oct 2023

Last checked

31 Oct 2023

Medium riskHealth Canada

An official Health Canada notice concerns Karl storz injection needles. Validation testing of the efficacy of the manual cleaning for the injection needle was performed. The testing showed that the required efficacy level was not achieved. Different scenarios were tested, and all possible manual cleaning steps included, and the residual protein value remained above the acceptance criteria. Recall start date: October 16, 2023 Published 2023-10-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74500

Official notice

2023-10-31

The hazard

Validation testing of the efficacy of the manual cleaning for the injection needle was performed. The testing showed that the required efficacy level was not achieved. Different scenarios were tested, and all possible manual cleaning steps included, and the residual protein value remained above the acceptance criteria. Recall start date: October 16, 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

74500

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Affected products

Product 1

Affected products - Flexible Injection Needle, Lot or serial number - All lots., Model or catalog number - 27182A

Product 2

Affected products - Injection Needle, Lot or serial number - All lots., Model or catalog number - 26175 PD 810506 8598D

Product 3

Affected products - Laryngeal Injection Needle, Lot or serial number - All lots., Model or catalog number - 8598B 8598A

Risk / hazard

Validation testing of the efficacy of the manual cleaning for the injection needle was performed. The testing showed that the required efficacy level was not achieved. Different scenarios were tested, and all possible manual cleaning steps included, and the residual protein value remained above the acceptance criteria. Recall start date: October 16, 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: Karl Storz Se Kg, Karl Storz Injection Needles.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74500

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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