Hemospray Kit
Brand(s)
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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