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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-11-10-24-624
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Tracheal Tube Reusable Introducer and Guides
الأجهزة المتأثرة
Description (SKU, Date of Manufacture): Tracheal Tube Introducer Woven Coude Tip 15CH 60cm (14-504-17, 28-Sep-2019 through 27-Dec-2022) Tracheal Tube Guide Woven Straight 15CH 70cm (14-504-68, 12-Dec-2019 through 24-Dec-2022) Tracheal Tube Guide Woven Straight 10CH 70cm (14-504-76, 03-Sep-2019 through 12-May-2022) Please refer to the attachment for the impacted lots.
الممثل المعتمد
AL MADAR MEDICAL SERVICES COMPANY
سبب المشكلة
A potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
الإجراء التصحيحي
Check all inventory locations within your institution for the affected product numbers listed in the attachment and discontinue use. Destroy all affected products following your institution’s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. Smiths Medical will provide full credit to affected customers, refer to the attachment for more information.
المرفقات
عودة للقائمة
