Health product recall

Catheter Valve Introducers

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 product - Medical device - 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