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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 127 04 18 000
Date submitted: 4/26/2018
Manufacturer:Saudi Mais for Medical Products
Device Type:Sterile Single Use Spinal needle with Introducer
Description:Needles, Injection
Medical Device Identifier:Product Lot Numbers: 3j818F & K811
Reason of Field Safety Corrective Action:The affected needle may not enter the introducer. This was identified that few introducers are packed with small hole size in which case function of spinal needle is expected to be compromised.
Remedy Action:The manufacturer request you to check your inventory for the product within the scope of this field action. Stop the distribution of stock of these both Lots and Quarantine immediately.
If these both lots are being in use by medical staff, it is advised to check carefully that the spinal needle is entered in introducer as in normal use.
In other case the manufacturer recommend you to cease use of these lots and quarantine as Saudi Mais customer services will collect the affected products.
The manufacturer will be replacing the remaining effected quantities with the good one.
Athorized Representative/Importer/Distributor:Saudi Mais Co. For Medical Products
Report Source:NCMDR
Source Ref. Number:AA67C65B27259
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Saudi Mais.pdf