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Hemospray® endoscopic hemostat

Official notice

9 Sept 2024

Last checked

9 Sept 2024

Critical riskHealth Canada

An official Health Canada notice concerns Hemospray® endoscopic hemostat. Cook Medical has identified that 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. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: August 30, 2024 Published 2024-09-09.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76022

Official notice

2024-09-09

The hazard

Cook Medical has identified that 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. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: August 30, 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

76022

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Affected products

Product 1

Affected products - Hemospray® Endoscopic Hemostat, Lot or serial number - W4851088 W4850662, Model or catalog number - HEMO-10 HEMO-7

Risk / hazard

Cook Medical has identified that 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. This can lead to the activation knob and carbon dioxide cartridge exiting the handle with force. Recall start date: August 30, 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® Endoscopic Hemostat.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

critical

Recall details

Recall number

76022

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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