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Exalt model d single-use duodenoscope

Official notice

14 Mar 2022

MediumHealth Canada

An official Health Canada notice concerns Exalt model d single-use duodenoscope. Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to perforations in the product labeling, and to communicate the intent to update the instructions for use with this information. Recall start date: Mar 3, 2022 Published 2022-03-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63991

Official notice

2022-03-14

The hazard

Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to perforations in the product labeling, and to communicate the intent to update the instructions for use with this information. Recall start date: Mar 3, 2022

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

63991

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Affected products

Product 1

Affected Products - Exalt Model D Single-Use Duodenoscope, Lot or Serial Number - All lots., Model or catalog number - M00542420, M00542421, M0054242CE0, M0054242CE1

Risk / hazard

Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to perforations in the product labeling, and to communicate the intent to update the instructions for use with this information. Recall start date: Mar 3, 2022

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, Exalt Model D Single-use Duodenoscope.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

63991

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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