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Magec 2 device

Official notice

24 Nov 2022

Last checked

24 Nov 2022

Medium riskHealth Canada

An official Health Canada notice concerns Magec 2 device. Recall relates to a packaging closure integrity issue. Investigation revealed a small population (3.8%) of packaged units have an undersized o-ring gland diameter that can affect the o-ring compression when the hard cap is affixed to the packaging tube. This lack of full compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system. Recall start date: November 1, 2022 Published 2022-11-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

72218

Official notice

2022-11-24

The hazard

Recall relates to a packaging closure integrity issue. Investigation revealed a small population (3.8%) of packaged units have an undersized o-ring gland diameter that can affect the o-ring compression when the hard cap is affixed to the packaging tube. This lack of full compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system. Recall start date: November 1, 2022

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

72218

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Affected products

Product 1

Affected products - Magec 2 (Marketed As Magec X) Device (Various Rod Sizes And Lot Numbers), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - MC2-5590S MC2-6090S MC2-4570S MC2-5070S MC2-4590S MC2-5090S MC2-5570S MC2-6070S

Product 2

Affected products - Magec 2 (Marketed As Magec X) Device (Various Rod Sizes And Lot Numbers), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - MS2-6090R MC2-4590R MC2-5070R MC2-4570R MC2-5590R MC2-6070R MC2-5570R MC2-5090R

Risk / hazard

Recall relates to a packaging closure integrity issue. Investigation revealed a small population (3.8%) of packaged units have an undersized o-ring gland diameter that can affect the o-ring compression when the hard cap is affixed to the packaging tube. This lack of full compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system. Recall start date: November 1, 2022

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: Specialized, Magec 2 Device.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

72218

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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