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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 183 07 13 000
Date submitted: 7/28/2013
Manufacturer:Baxter Healthcare
Device Type:Various Irrigation Sets Used with UROMATIC and ARTHROMATIC Plastic Containers
Description:Irrigators, Surgical Site
Medical Device Identifier:Product codes (2C4013; 2C4030; 2C4031). Product code 2C4030 was distributed in Saudi Arabia between 2001 and 2006.
Lot numbers: ( U580647R, UR123497, UR123612, UR127241, UR187971, UR232744, UR254078, UR287730 & UR312652 )
Reason of Field Safety Corrective Action:Baxter would like to notify you of a recall of the above mentioned product due to the discovery of pinholes defects in the clear bottom film of the packaging.
A potential outcome of a breach in sterile packaging is contamination of the surgical field, which may lead to patient infection.
Remedy Action:Locate and remove the affected product code numbers listed above from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to them to ensure that they also locate and remove the affected products.
Athorized Representative/Importer/Distributor:Arabian Health Care Supply Co. (AHCSC), Riyadh, (011) 4747444
Report Source:NCMDR
Source Ref. Number:7F276FCC34215
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Baxter.pdf