현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
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We have received occasional complaints of betafine universal pen needles 30g-8mm with lot
number 513061 and have therefore decided to proactively take action and recall this product.
sporadically, the steel cannula becomes stuck in the rubber seal of the pen’s insulin cartridge
after insulin injection. in such instances, there exists a slight danger of pricking oneself with the
already used cannula. the cause has already been established and resolved and therefore we
can assure you that only pen needles from lot number513061 can be affected by this issue.