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Hemospray® Kit — recall 77347

Health Canada — Medical Devices · Canada · 2025-04-28 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 77347
Date of alert: 2025-04-28
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Gastroenterology and urology
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hemosprayr-kit

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Hemospray® Kit — recall 77347

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