التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

- Review your inventory for the affected product codes.

- Post a copy of the attachment in your storeroom and clinical areas. 

- Cardinal Health are evaluating the labeling, IFU, & design of the ARV to facilitate proper use, functionality and limit device replacement, refer to important instructions below:
After placement of the Salem Sump tube, always inject 10ml-20ml of air before seating the Anti Reflux Valve (ARV) into the blue sump vent lumen.
Instructions:
1. Seat the BLUE END of the ARV into the blue sump vent lumen of the Salem Sump tube. Insert the ARV gently into the Salem Sump tube to avoid difficult removal.
2. To cap tube, seat the WHITE END of the ARV into the suction lumen. Insert the ARV gently into the Salem Sump tube to avoid difficult removal.
3. To remove, pull valve in the same direction of assembly. Do not pull at an angle to avoid breaking the valve.

- Electronic IFUs are in the process of been updated and will be available in the coming weeks at https://www.mycardinalmsds.com.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-07-10-25-1085