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Flexor® check-flo introducer and rösch-uchida transjugular liver access sets

Official notice

3 Dec 2025

MediumHealth Canada

An official Health Canada notice concerns Flexor® check-flo introducer and rösch-uchida transjugular liver access sets. Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and/or not inspected properly. Published 2025-12-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81316

Official notice

2025-12-03

The hazard

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and/or not inspected properly.

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

81316

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Affected products

Product 1

Affected products - Rösch-Uchida Transjugular Liver Asset Set, Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - RUPS-100

Product 2

Affected products - Flexor® Check-Flo Introducer Set, Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - KCFW-10.0-38-80-RB

Product 3

Affected products - Flexor® Check-Flo Introducer Set, Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - KCFW-10.0-38-40-RB

Product 4

Affected products - Flexor® Check-Flo Introducer Set, Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - KCFW-12.0-38-80-RB

Product 5

Affected products - Flexor® Check-Flo Introducer Set, Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - KCFW-12.0-38-40-RB

Product 6

Affected products - Flexor® Check-Flo Introducer Set, Lot or serial number - More than 20 numbers, contact manufacturer., Model or catalogue number - KCFW-10.0-38-RB

Risk / hazard

Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and/or not inspected properly.

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

Brand: Cook, Flexor® Check-flo Introducer And Rösch-uchida Transjugular Liver Access Sets.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81316

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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