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Uropass ureteral access sheath
Official notice
18 Oct 2024
Last checked
18 Oct 2024
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 determined that exposing the Uropass product to ultraviolet ("UV") radiation can cause brittleness of the device dilator tip, which may lead to breakage. Since April 2023, Olympus has received 2 adverse event complaints reporting broken Uropass dilator tips for devices still within their shelf life. Recall start date: October 4, 2024 Published 2024-10-18.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76357
Official notice
2024-10-18
The hazard
The hazard
Olympus conducted an investigation after receiving complaints reporting broken dilator tips in the package and in patients during surgical procedures. The investigation determined that exposing the Uropass product to ultraviolet ("UV") radiation can cause brittleness of the device dilator tip, which may lead to breakage. Since April 2023, Olympus has received 2 adverse event complaints reporting broken Uropass dilator tips for devices still within their shelf life. Recall start date: October 4, 2024
How to check if you're affected
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
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Gyrus Acmi, Uropass Ureteral Access Sheath.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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