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الأربعاء - شعبان 6, 1446
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EN
SA-03-09-24-583
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Automated Compounding Device Inlet
الأجهزة المتأثرة
Product Code : H938173 - H938174 - H938175 - H938176 Lot Numbers: All within expiry
الممثل المعتمد
Baxter AG
سبب المشكلة
Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use. This issue only affects the disposable inlets and does not affect the ExactaMix or ExactaMix Pro compounder devices.
الإجراء التصحيحي
Baxter is working to rectify the issue detected with the affected products. During this period, customers who do not observe particulate matter may continue to use the inlets as outlined in the 'Actions to be Taken by Customers' section in the attached letter. Customers should not use the disposable inlet if particulate matter is observed. The ExactaMix and ExactaMix Pro compounding devices can continue to be used with inlets where no particulate matter is observed. Customers can order replacement ExactaMix inlets if particulate matter in the inlet is observed
المرفقات
عودة للقائمة
