Health product recall

Quantum TTC® Biliary Balloon Dilator

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
QBD-8X3-E
OBID-1
QBD-1
QBD-10X3
QBID-1
QBD-10X3-E
QBD-6X3-E
QBD
QBD-6X3
OBD-1
QBD-8X3

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: 2023-11-20
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