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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Swissmedic Recall
Reference Number: mdprc 055 05 18 000
Date submitted: 5/13/2018
Manufacturer:Chart Inc.
Device Type:Aluminum Dewars
Description:Liquid nitrogen container
Medical Device Identifier:Aluminum Dewars with Serial Number Range: NPB201750xxxxx through NPB201752xxxxx and NPB201801xxxxx through NPB201810xxxxx (manufactured Week 50 of 2017 through Week 10 of 2018).
Reason of Field Safety Corrective Action:Chart is presently investigating the possible cause of the VACUUM LEAK AND/OR FAILURE which may be due to inadequate adhesion of the composite neck to the aluminum unit.
Remedy Action:If you have a unit in question (within the serial number range noted above) you must:

-Immediately remove the unit(s) from service; AND, EITHER:

-Return to Chart Inc.; OR

-After following the standard procedures to empty the unit, drill a hole in the retired unit near the serial number. Drilling the unit will assure the unit is not returned to service. Email or transmit photographic evidence to Chart of compliance with this Recall notice, depicting the hole and serial number (as depicted in the image below)(if you are not familiar with how to safely complete this process, simply return the unit to Chart).
Athorized Representative/Importer/Distributor:N/A
Report Source:Swissmedic
Source Ref. Number:Vk_20180503_03
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20180503_03 ( Chart ).pdf