تسجيل الدخول
تسجيل جديد
الجمعة - جمادى الآخرة 26, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-10-11-24-668
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
LIAISON Q.S.E.T. Device Plus
الأجهزة المتأثرة
Unique Device Identifier(s) (UDI-DI): 80567713190605F Device Model/Catalogue/part number(s): 319060 Affected serial or lot number range: 225084, 233154, 223244, 230094, 259144, 224244, 219104, 228174, 251234, 232094, 236174, 252244, 224124, 210204, 223274, 217134 , 221214, 221294, 234114, 228224, 232294, 205144, 229224, 222314.
الممثل المعتمد
Abdulla Fouad For Medical Supplies and Services Company
سبب المشكلة
Internal investigation by the manufacturer has determined that 0.14% of the tubes in the lots identified may have loose clear caps. The loose clear caps may allow leakage of the buffer from the tube.
الإجراء التصحيحي
Devices should be inspected for loose clear caps prior to use. The user should confirm that the clear cap is tight by grasping the cap and twisting. If the cap is loose, the device should be discarded. Do not attempt to use the device as the loose clear cap may have allowed the buffer to leak and the buffer volume may be insufficient. Manufacturer Action: Instructions and Removal.
المرفقات
عودة للقائمة
