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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 088 08 14 000
Date submitted: 8/19/2014
Manufacturer:Total Healthcare Innovation GmbH
Device Type:OXYGEN Sterile Protection
Description:cover, barrier, protective
Medical Device Identifier:A limited number of OXYGEN Sterile Protection PN 60200 is affected by this action. THI has identified the LOT number of all affected products.
LOT : 201401
Reason of Field Safety Corrective Action:In a limited number of the product OXYGEN Sterile Protection (PN: 60200), a protective green cover foil that protects the transparent part of the lens hood system is not removed after the assembling process.
Remedy Action:Please inform your customers who received the affected LOT that there might be some products with an additional layer. If you have an affected product (product with and additional foil), contact THI GmbH for replacement.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:INC-AT-14-07-000006
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: block_docupload_V1_01_doc_Field Safety Notice.pdf