Health product recall

Hemospray Kit

Last updated

Summary

Product
Hemospray Kit
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Hemospray Kit All lots. HEMO-10 HEMO-7

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies

Wilson-Cook Medical, Inc. 

4900 Bethania Station Rd., Winston Salem, North Carolina, United States, 27105

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73733

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