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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 168 02 12 000
Date submitted: 2/25/2012
Manufacturer:Covidien
Device Type:Tubing and Syringes, Disposable Imaging Device Accessories;
Description:Tubing and Syringes
Medical Device Identifier:Catalog: 801104, Product: 60 mL Syringe, MR, w/lateral flow needle. Catalog: 801103, Product: 25 mL Syringe, MR, w/lateral flow needle. Catalog: 801801, Product: 60 mL Syringe, MR, w/lateral flow needle. Catalog: 801106, Product: 60" Y Tubing, MR, with single check valve. Catalog: 801107, Product: 90" Y Tubing, MR, with single check valve. Catalog:: 601195. Product: 60" Coiled Extension Tubing, low pressure. *Lots Attached*
Reason of Field Safety Corrective Action:Covidien has identified sterilized packages of these products that are unsealed.
Remedy Action:Please check your inventory of these products. If any of the affected products are in your inventory, please discontinue use of the products immediately. Customers will be contacted by Customer Services to arrange return of the products.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCMDR
Source Ref. Number:78E06140BD2B6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Covidien.pdf