Quantum TTC® Biliary Balloon Dilator
Brand(s)
Last updated
Summary
Product
Quantum TTC® Biliary Balloon Dilator
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 |
|---|---|---|
Quantum TTC® Biliary Balloon Dilator |
All lots. |
QBD-4X3 |
Issue
Wilson-Cook Medical, Inc. is initiating a voluntary removal of affected QBD devices from the market because they are nonconforming. They are manufactured correctly, but do not comply the design requirements. Devices were not able to inflate without leakage.
Recall start date: November 3, 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-74616
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