تسجيل الدخول
تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-10-02-25-781
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Silvercel Hydro Alginate, Silvercel Non-Adherent, Tegaderm Alginate, ActivHeal Alginate, ActivHeal Aquafibre, ActivHeal Non-Adhesive Foam, ActivHeal Non Adhesive Tracheostomy, ActivHeal PHMB Foam Non-Adhesive, ActivHeal Raponicel Ultra, Biatain Alginate, Hyalo 4 High Gelling Fibre, Calcicare Reinforced Alginate, Reinforced Aquafibre, Nurocel Extra, Maxorb Extra
الأجهزة المتأثرة
The affected references and lots are detailed in the attachment, please refer to it.
الممثل المعتمد
Medical Regulations Gate
سبب المشكلة
A defect on primary packaging pouches in the products listed above, in which minor missing patches of Polyethylene have been detected. The defect on these pouches could compromise the device’s ability to maintain a sterile barrier.
الإجراء التصحيحي
-Where Product has already been used in patients under a three-month time period, patients should be monitored for symptoms during routine clinical follow up, refer to the attachment for more details. -Immediately inspect your internal inventory for the aforementioned packaging defect and quarantine all affected Product and execute actions in accordance with the attachment. -Defect product will be replaced, please contact AMS representative. Manufacturer action: Instructions and Removal.
المرفقات
عودة للقائمة
