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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 052 05 13 000
Date submitted: 5/15/2013
Manufacturer:Covidien LLC
Device Type:5 mm Versaport Bladeless Optical Trocars with Fixation Cannulae
Description:Trocars, Abdominal , Thoracic , Cannulae
Medical Device Identifier:Product numbers :- ONBFCA5ST, ONBFCA5SH, ONB5STF2C, ONB5STF, ONB5LGF, ONB5SHF, USUONB5LGF, USUONB5SHF, USUONB5STF, USUONBFCA5ST, Lot numbers NOT affected: N2H0045X, N2H0166X, N2H0286X, N2H0357X, N2H0516UX. Please see the attachment
Reason of Field Safety Corrective Action:Seal May Disengage and Fall into Patient Cavity
Remedy Action:Identify, isolate, and discontinue use of any affected product in your inventory.
Athorized Representative/Importer/Distributor:Covidien AG , Jeddah, (02) 6623153
Report Source:NCMDR
Source Ref. Number:CCDD9675D838C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: COVIDIEN.pdf