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Uropass ureteral access sheath

Official notice

19 Jun 2023

Last checked

19 Jun 2023

Medium riskHealth Canada
Watch Gyrus Acmi

An official Health Canada notice concerns Uropass ureteral access sheath. Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation showed that reported breakages were associated with devices aged more than three years. Devices manufactured after December 31st, 2019 are not impacted by this recall. Recall start date: June 5, 2023 Published 2023-06-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73851

Official notice

2023-06-19

The hazard

Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation showed that reported breakages were associated with devices aged more than three years. Devices manufactured after December 31st, 2019 are not impacted by this recall. Recall start date: June 5, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

73851

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Affected products

Product 1

Affected products - UroPass Ureteral Access Sheath, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 61038BX 61054BX 61146BX 61246BX 61138BX 61324BX 61024BX 61046BX 61254BX 61154BX 61346BX 61354BX 61124BX 61238BX 61224BX 61338BX

Risk / hazard

Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation showed that reported breakages were associated with devices aged more than three years. Devices manufactured after December 31st, 2019 are not impacted by this recall. Recall start date: June 5, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Gyrus Acmi, Uropass Ureteral Access Sheath

Manufacturer

Not provided

Phone

Not provided

Brand: Gyrus Acmi, Uropass Ureteral Access Sheath.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73851

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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