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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-08-10-25-1087
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
FreeGo Enteral Feeding set
الأجهزة المتأثرة
Refer to the attachment.
الممثل المعتمد
Abbott Saudi Arabia For Trading LLC
سبب المشكلة
Some customers are using the FreeGo Enteral Feeding Sets in a manner inconsistent with the labeling, which has the potential to pose a health risk.
الإجراء التصحيحي
The attachment is being issued by Abbott to reinforce the Instructions for Use regarding the correct use of the FreeGo Enteral Feeding set. The following IFU regarding the enteral feeding sets should be followed: - Do not alter the feeding set in any way before use as this may impact the performance of the set. - No modification of this equipment is allowed including the pump, disposable set, and accessories. - Connect the Abbott FreeGo feeding set securely to the enteral feeding tube. Ensure all connections are clean and dry. Take care not to over-tighten the connections. - Ensure the flush port is open from the pump to the patient before beginning therapy. The lilac handle of the flush port should be pointed in the direction (perpendicular) to the lilac cap of the flush port to allow flow to the patient. Please refer to "Recommended actions to be taken by the Healthcare Professionals, Caregivers, and Users" in the attachment. Manufacturer's Action: Instructions.
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