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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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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
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