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Soclean 2 automated supplemental pap maintenance device

Official notice

16 May 2022

Last checked

16 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Soclean 2 automated supplemental pap maintenance device. Labelling changes were issued for the Soclean 2 such as 1) running the Soclean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of microorganisms, 2) Soclean 2 is not an automated pap disinfecting system but rather an automated supplemental pap maintenance device, 3) users must follow the CPAP-manufacturer's instructions for cleaning their pap accessories and 4) the Soclean 2 is intended for use with single-user, personal at-home-use pap device accessories. Recall start date: Sept 7, 2021 Published 2022-05-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64168

Official notice

2022-05-16

The hazard

Labelling changes were issued for the Soclean 2 such as 1) running the Soclean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of microorganisms, 2) Soclean 2 is not an automated pap disinfecting system but rather an automated supplemental pap maintenance device, 3) users must follow the CPAP-manufacturer's instructions for cleaning their pap accessories and 4) the Soclean 2 is intended for use with single-user, personal at-home-use pap device accessories. Recall start date: Sept 7, 2021

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

64168

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Affected products

Product 1

Affected products - SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE, Lot or Serial Number - All lots., Model or catalogue number - SC1200.CA

Risk / hazard

Labelling changes were issued for the Soclean 2 such as 1) running the Soclean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of microorganisms, 2) Soclean 2 is not an automated pap disinfecting system but rather an automated supplemental pap maintenance device, 3) users must follow the CPAP-manufacturer's instructions for cleaning their pap accessories and 4) the Soclean 2 is intended for use with single-user, personal at-home-use pap device accessories. Recall start date: Sept 7, 2021

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: Soclean, Soclean 2 Automated Supplemental Pap Maintenance Device.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64168

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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