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Hemospray® kit

Official notice

28 Apr 2025

Last checked

28 Apr 2025

Critical riskHealth Canada

An official Health Canada notice concerns Hemospray® kit. A limited number of nonconforming raw materials were manufactured into certain lot numbers of Hemospray® devices and distributed into the field. Use of the devices with these nonconforming raw materials may result in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated, prior to and during use, or after the procedure is complete. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: November 4, 2024 Published 2025-04-28.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77347

Official notice

2025-04-28

The hazard

A limited number of nonconforming raw materials were manufactured into certain lot numbers of Hemospray® devices and distributed into the field. Use of the devices with these nonconforming raw materials may result in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated, prior to and during use, or after the procedure is complete. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: November 4, 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

77347

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Affected products

Product 1

Affected products - Hemospray® Kit, Lot or serial number - More than 30 numbers, contact manufacturer., Model or catalog number - HEMO-10 HEMO-7

Risk / hazard

A limited number of nonconforming raw materials were manufactured into certain lot numbers of Hemospray® devices and distributed into the field. Use of the devices with these nonconforming raw materials may result in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated, prior to and during use, or after the procedure is complete. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: November 4, 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: Wilson-cook Medical, Hemospray® Kit.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

77347

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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