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Health Canada Medical devices

Hemospray Kit

Issued May 31, 2023
Issue
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
Hazard description
Performance
Product
Product name
Hemospray Kit
Reference
ID
RA-73733