www.mhlw.go.jp/stf/newpage_45109.html
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医薬品医療機器等法に基づく行政処分を行いました｜厚生労働省
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https://www.mhlw.go.jp/stf/newpage_45109.html
About this page
This page announces an administrative action taken by Japan's Ministry of Health, Labour and Welfare on November 8, 2024. Medtronic Japan Co., Ltd. failed to report defect cases of its insulin pump infusion set within the required deadline. The ministry issued a business improvement order based on the Pharmaceutical Affairs Law. However, the ministry determined there is no risk to product efficacy and safety, nor any health hazards, so no additional measures such as labeling revisions or product recalls are necessary. No health incidents have been reported.
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