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Autotome rx

Official notice

3 Jul 2024

CriticalHealth Canada

An official Health Canada notice concerns Autotome rx. Boston Scientific is initiating a removal of one lot of Autotome Cannulating Sphincterotomes due to reports of the presence of foreign material on the enclosed section of the cutting wire, between the handle and the distal end of the device which may lead to inability to optimally bow the sphincterotome. Recall Start Date: June 12, 2024 Published 2024-07-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75778

Official notice

2024-07-03

The hazard

Boston Scientific is initiating a removal of one lot of Autotome Cannulating Sphincterotomes due to reports of the presence of foreign material on the enclosed section of the cutting wire, between the handle and the distal end of the device which may lead to inability to optimally bow the sphincterotome. Recall Start Date: June 12, 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

75778

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Affected products

Product 1

Affected products - Autotome RX, Lot or serial number - 33280747, Model or catalog number - M00545170

Risk / hazard

Boston Scientific is initiating a removal of one lot of Autotome Cannulating Sphincterotomes due to reports of the presence of foreign material on the enclosed section of the cutting wire, between the handle and the distal end of the device which may lead to inability to optimally bow the sphincterotome. Recall Start Date: June 12, 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: Boston Scientific, Autotome Rx.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

75778

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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