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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 035 10 12 000
Date submitted: 10/13/2012
Manufacturer:BD Diagnostic Systems
Device Type:BD Oral Dispensing Syringe
Description:Oral Dispensing Syringe
Medical Device Identifier:Catalogue number: 305217 & 305219; lot/batch number(s): 2055156/2020057/2020056/1346419; Device Manufacturing date: Jan-April 2012; Expiry date: N/A – Product non sterile
Reason of Field Safety Corrective Action:BD is conducting a recall on the above referenced product (1ml & 10ml non-sterile oral syringes) with the specific lot numbers listed. A small percentage of syringes labelled as oral syringes, have a luer tip that has the potential to be inadvertently attached to other luer devices, e.g. I.V. catheters.
Remedy Action:Identify, quarantine and return any stocks of the products listed above to BD.
Athorized Representative/Importer/Distributor:Becton Dickinson B.V., Riyadh, (01) 4727933
Report Source:NCMDR
Source Ref. Number:02B3FEFDF23A2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments