تسجيل الدخول
تسجيل جديد
الخميس - شوال 5, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-13-02-25-786
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Sedaconda Syringe
الأجهزة المتأثرة
UDI-DI for SKU (box of syringes) 05391530290692 REF number: 1026022 Please refer to the attachment for affected lot numbers.
الممثل المعتمد
Techno Orbits Company
سبب المشكلة
A potential issue has been identified with the connection between the syringe (filled with isoflurane or sevoflurane) and the delivery line to the Sedaconda ACD. In some cases, this connection may experience leakage, leading to reduced or interrupted delivery of the drug.
الإجراء التصحيحي
Affected customers are provided with immediate access to the updated IFU and e-guide. Instructions For Use Sedaconda ACD Rev 5, specifically 5.3 Point 6 and Instructions For Use Sedaconda Syringe Rev 1, specifically Picture 3, refer to the attachment for more details. Manufacturer action: Instructions and correction.
المرفقات
عودة للقائمة