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Magic3 go intermittent silicone catheter

Official notice

9 May 2023

MediumHealth Canada

An official Health Canada notice concerns Magic3 go intermittent silicone catheter. BD observed a nonconforming condition where some catheters manufactured had the clear resealing label separating from the product foil pouch, resulting in a possible path into the product packaging that could potentially result in a sterile barrier breach if the delamination reached the foil opening in the foil package. Recall start date: April 20, 2023 Published 2023-05-09.

What to do now

Review notice & share with customers/users, discontinue sale/usage of inventory & dispose, return reply form.

Recall number

73646

Official notice

2023-05-09

The hazard

BD observed a nonconforming condition where some catheters manufactured had the clear resealing label separating from the product foil pouch, resulting in a possible path into the product packaging that could potentially result in a sterile barrier breach if the delamination reached the foil opening in the foil package. Recall start date: April 20, 2023

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

73646

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Affected products

Product 1

Affected products - Magic3 Go Intermittent Silicone Catheter, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 51816 51814 51810 53812G

Risk / hazard

BD observed a nonconforming condition where some catheters manufactured had the clear resealing label separating from the product foil pouch, resulting in a possible path into the product packaging that could potentially result in a sterile barrier breach if the delamination reached the foil opening in the foil package. Recall start date: April 20, 2023

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: C.r Bard, Magic3 Go Intermittent Silicone Catheter.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

73646

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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