Recall MonitorHealth Products
Hemospray® Kit
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Hemospray® Kit
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Hemospray® Kit | More than 30 numbers, contact manufacturer. | HEMO-10 HEMO-7 |
Issue
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