SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE
Brand(s)
Last updated
Summary
Product
SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or Serial Number | Model or catalogue number |
|---|---|---|
| SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE | All lots. | SC1200.CA |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Soclean Inc.
12 Vose Farm Road, Peterborough, New Hampshire, United States, 03458
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-64168
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