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Hemospray kit

Official notice

31 May 2023

Last checked

31 May 2023

Medium riskHealth Canada

An official Health Canada notice concerns Hemospray kit. Currently, the Hemospray instructions for use states "Potential complications: when spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning / removing the endoscope, particularly if passing through a strictured area." The risk to health section of this letter provides additional information that is not currently in the Hemospray instructions for use. Recall start date: May 23, 2023 Published 2023-05-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73733

Official notice

2023-05-31

The hazard

Currently, the Hemospray instructions for use states "Potential complications: when spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning / removing the endoscope, particularly if passing through a strictured area." The risk to health section of this letter provides additional information that is not currently in the Hemospray instructions for use. Recall start date: May 23, 2023

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

73733

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Affected products

Product 1

Affected products - Hemospray Kit, Lot or serial number - All lots., Model or catalog number - HEMO-10 HEMO-7

Risk / hazard

Currently, the Hemospray instructions for use states "Potential complications: when spraying in the retroflexed position, Hemospray powder may adhere to the outside of the endoscope. This may result in difficulty repositioning / removing the endoscope, particularly if passing through a strictured area." The risk to health section of this letter provides additional information that is not currently in the Hemospray instructions for use. Recall start date: May 23, 2023

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: Wilson-cook Medical, Hemospray Kit.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73733

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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