تسجيل الدخول
تسجيل جديد
الخميس - محرم 8, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-21-01-25-752
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Sterile Container System and AESCULAP Aicon® Sterile Container System
الأجهزة المتأثرة
Please refer to the attachment for more details of the affected devices.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
If anodized aluminum (The Device is made of anodized aluminum) is subject to cleaning/disinfection solutions outside the defined pH range and inappropriate re-processing parameters (water quality, temperature and duration of the drying phase), white residues (oxygen-containing aluminum compounds) may form on the Device’s inner and/or outer surface. The white residues do not influence form, fit and function and the safety and efficacy of the Device.
الإجراء التصحيحي
Every user is instructed to take note of the updated IFU and, in the event of occurrence of white residues on its Sterilization Containers, to review the internal reprocessing procedures accordingly. The instruction for use (IFU) has been updated accordingly with the changes in the attachment. Manufacturer action: instructions and correction.
المرفقات
عودة للقائمة
