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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-16-12-24-706
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Sevoflurane vaporizers
الأجهزة المتأثرة
Item number (Getinge Order Reference) 6682282 (Vaporizer Sevoflurane Maquet filling) 6887135 (Vaporizer Sevoflurane SAFE-T-SEAL) 6682285/6886611 (Vaporizer Sevoflurane, Quik-Fil) Serial number: All units Consignee list EVU-262259
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
Sevoflurane is susceptible to degradation, which can occur through contamination with strong Lewis acids. The aluminum container in the vaporizer is designed to ensure product stability during expected clinical practice but is not intended for long-term storage of sevoflurane. Furthermore, product stability is only verified with the specific brand of anesthetic agent it is intended to be used with.
الإجراء التصحيحي
All users of Getinge/Maquet sevoflurane vaporizers, both existing and new, please pay attention to the following information: 1. Do not leave sevoflurane in the vaporizer for a longer period than 30 days or during external transportation. The vaporizers must be emptied if the sevoflurane is not planned to be used within the next 30 days or before external transportation. Empty and dry-run the vaporizer according to instructions in the User´s Manual and Appendix 1 in the attachment. 2. Prior to using a vaporizer containing sevoflurane, ensure that the vaporizer has been in use within the most recent 30 days. If the sevoflurane has not been used during the most recent 30 days, it must be discarded. Empty and dry-run the vaporizer according to instructions in the User´s Manual and Appendix 1 in the attachment. 3. As already stated in the User’s Manual, Sevoflurane vaporizers are only tested for use according to the table in the attachment, refer to it for more details. Manufacturer Action: Instructions.
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