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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-20-10-24-633
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Minicap Extended Life PD Transfer Set with Twist Clamp
الأجهزة المتأثرة
Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp), Transfer Set (MiniCap Extended Life PD Transfer Set with Twist Clamp)
الممثل المعتمد
Baxter AG
سبب المشكلة
the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.
الإجراء التصحيحي
Baxter will continue to make the existing peroxide-cured silicone tubing configuration of the transfer sets available in your country until this transition occurs, as there is currently no definitive data to demonstrate that a patient safety risk exists. Please continue your prescribed PD therapy. If you have any questions about your PD therapy, please contact your doctor and/or nurse. Action Update: Please refer to the attachment for the update from the manufacture.
المرفقات
عودة للقائمة
