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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 070 02 16 000
Date submitted: 2/22/2016
Manufacturer:3M Health Care Ltd
Device Type:3M Steri-Vac™ Gas Sterilizer/Aerator
Description:Gas Sterilizer/Aerator
Medical Device Identifier:Models 5XL and 8XL.
Reason of Field Safety Corrective Action:Recently, during inspection of incoming components from a supplier, 3M discovered a valve with incorrectly labeled “input” and “output” orientation.
Remedy Action:If you have received this notice from 3M, then our records indicate you have a sterilizer within the scope of the field correction. These units may have an improperly labeled valve.

3M Service will be contacting you to schedule an appointment to inspect the subject valve in your unit(s). There is no reliable method for an untrained individual to determine if a sterilizer is affected; a trained service technician must assess the valve in person. In the meantime, you may continue using your sterilizer(s).
Athorized Representative/Importer/Distributor:3M company
Report Source:NCMDR
Source Ref. Number:DBF60ED3352E7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: 3M Health Care.pdf