تسجيل الدخول
تسجيل جديد
الأحد - ذو الحجة 5, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-13-10-24-626
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Nutrifix Bag – Infusomat Space Line ENFit
الأجهزة المتأثرة
Article Number (Article Name, Batch Number): 8700380 (INF. PLUS LINE ENTERAL W.1000ML NUTR.BAG, 21H16F0000) 8700380 (INF. PLUS LINE ENTERAL W.1000ML NUTR.BAG, 24B01F0000) 8250839SP (INF.SP. LTG,1000ML NUTRIFIX,PVC,LL,230CM, 23H16F0000) 8250839SP (INF.SP. LTG,1000ML NUTRIFIX,PVC,LL,230CM, 23H25F0000) 8250839SP (INF.SP. LTG,1000ML NUTRIFIX,PVC,LL,230CM, 23K01F0000) 8250839SP (INF.SP. LTG,1000ML NUTRIFIX,PVC,LL,230CM, 23K06F0000) Please refer to the attachment for more information.
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
Biocompatibility tests revealed a potential release of phthalate-containing plasticizers used in the PVC bag of the affected devices during intended use scenarios.
الإجراء التصحيحي
- Affected products should be used only in adult patients. - Pediatric patients should not be treated with affected articles. - It is not necessary to exchange devices from the affected batches, which are currently used in pediatric patients. Manufacturer action: Correction.
المرفقات
عودة للقائمة
