美国FDA一级召回，涉及雅培、泰利福、瑞思迈等一线厂商

admin · 发表于 2020-10-14 12:52:42

                  <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span>2月19日，FDA公布了3项一级召回，涉及雅培、泰利福医疗、瑞思迈等大型跨国医疗器械企业。</span><span>一级召回是FDA最严重的召回类型，可能会导致患者的严重伤害甚至是死亡。</span></p><p><br  /></p><p><span><strong>雅培对NCTrek RX冠状动脉扩张导管和NC Traveler RX冠状动脉扩张导管进行召回</strong></span></p><p><br  /></p><h2><span>FDA官网宣布，雅培对NCTrek RX冠状动脉扩张导管和NC Traveler RX冠状动脉扩张导管进行召回，型号为：</span><span>球囊直径4.0mm，4.5mm和5.0mm。</span><span>召回数量为13891，属于一级召回。</span></h2><p><span><br  /></span></p><p><p><img src="image/20201014/60e0c94992ab85ada027cf26894e02ee_2.png" /></p></p><p><br  /></p><h2><span>冠状动脉扩张导管用于打开堵塞的血管，以改善流向心脏的血液。</span><span>NC TREK RX冠状动脉扩张导管适用于为了改善心肌灌注。</span></h2><h2><span>召回原因：</span><span>受冲击批次的球囊可能未按预期放气。</span><span>此问题是由于在制造过程中过度暴露于热导致靠近气囊结合处的材料较弱。</span></h2><h2><br  /></h2><h2><span>使用这些设备可能会对患者导致严重的不良后果，例如长时间的心肌缺血、心肌梗塞以及可能导致手术的其他手术术后并发症，包括死亡。</span></h2><h2><span>目前，已收到13个与此问题有关的投诉，1人死亡。</span></h2><p><br  /></p><p><span><strong>泰利福对COMFORTFLO加湿系统，REF 2410，加湿器雾化器套件等不同版本产品进行召回</strong></span></p><p><br  /></p><p><span>泰利福对COMFORTFLO加湿系统，REF 2410，加湿器雾化器套件等不同版本产品也进行了召回。</span><span>召回数量为398320件，也属于一级召回。</span></p><p><br  /></p><p><p><img src="image/20201014/eaa1933d72186c1a4528f178ba34e098_3.png" /></p></p><p><br  /></p><p><span>据了解，Comfort Flo加湿系统用于为患者提供恒定流量的加热和加湿的呼吸气体，适于于新生儿，小儿和成人患者。</span></p><p><br  /></p><p><span>召回原因：</span><span>水可能会淹没色谱柱并进入系统回路，并且导致水可能会进入患者的鼻子和肺部。</span></p><p><br  /></p><p><span>该设备已收到102例投诉和8例伤害，目前没有死亡的报道。</span></p><p><br  /></p><p><span><strong>瑞思迈召回Stellar呼吸机</strong></span></p><p><br  /></p><p><span>FDA官网显示，瑞思迈召回的产品为Stellar呼吸机，型号为100和150，共计69台，属于一级召回。</span></p><p><br  /></p><p><span>召回原因：</span><span>在特定情况下，不会发出声音警报。</span><span>而导致严重的后果，包括造成严重伤害或死亡的风险。</span></p><p><br  /></p><p><span>整理自FDA官网，诺沃兰CMDRA </span></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br  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