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Catheter valve introducers

Official notice

14 Mar 2022

Last checked

14 Mar 2022

Medium riskHealth Canada
Watch Balt Extrusion Sas

An official Health Canada notice concerns Catheter valve introducers. 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 Published 2022-03-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63987

Official notice

2022-03-14

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

63987

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Affected products

Product 1

Affected Products - Catheter Valve Introducers, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - IVA3F50, IVA6F80ST, IVA6F80ST_MP, IVA6F80

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Balt Extrusion Sas, Catheter Valve Introducers

Manufacturer

Not provided

Phone

Not provided

Brand: Balt Extrusion Sas, Catheter Valve Introducers.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63987

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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