Catheter Valve Introducers
Brand(s)
Last updated
Summary
Product
Catheter Valve Introducers
Issue
Medical devices - Quality issue
What to do
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or Serial Number |
Model or catalog number |
|---|---|---|
Catheter Valve Introducers |
More than 10 numbers, contact manufacturer. |
IVA3F50, IVA6F80ST, IVA6F80ST_MP, IVA6F80 |
Issue
Balt Extrusion Sas identified a leak on the pouch near where the stopcock contacts the Tyvek transparent side of the pouch during a stability study. The pouch damage is not likely detectable before the clinical use of the device as the damage on the pouch may not be visible with the unaided eye. To prevent any issue with IVA products, Balt has deciced to recall all products from the market.
Recall start date: Feb 19, 2022
Additional information
Details
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Balt Extrusion Sas
10, Rue Croix-Vigneron, Montmorency
France, 95160
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63987