美国食品药品管理局11月10日发早期警示：Intersurgical移除22毫米光滑内腔呼吸管路，接头可能脱落、截至11月3日无重伤或死亡报告
美国食品药品管理局11月10日发布早期警示，称Intersurgical公司移除部分22毫米光滑内腔呼吸管路与系统，食品药品管理局器械与放射健康中心称这是一个潜在高风险器械问题，并将随新信息更新页面。警示发布时间为11月10日下午1时53分。
该局称，Intersurgical已向受影响客户发函，建议将相关呼吸系统从使用或销售场所移除。受影响产品包括型号5018000的22毫米光滑内腔管，带软端接头，规格22F至22F，长度不小于1.8米，所涉批次编号32511811见于警示页产品表。
警示所载原因为，制造中使用四氢呋喃溶剂将软接头粘合到光滑内腔管上，接头可能脱落。呼吸管路与系统用于连接患者与辅助呼吸的机器，接头脱落可导致通气丧失，并可能造成脑损伤或死亡，该局在警示摘要中如此列明风险。
处置为立即停用并隔离受影响批次，并将受影响产品退回Intersurgical。企业于11月3日向全部受影响客户发函。截至11月3日，Intersurgical报告无与此问题相关的重伤或死亡。
美国客户如有不良反应、质量问题或疑问，可联系Intersurgical客户服务，邮箱[email protected]，电话800-828-9633，联系方式见警示页原文。本稿只报道该局警示所载事实与联系资源，不作个体诊疗建议。
FDA Issues Early Alert on November 10: Intersurgical Removes 22mm Smoothbore Breathing Tubes, Connectors May Detach, No Serious Injuries or Deaths Reported as of November 3
The Food and Drug Administration issued an Early Alert on November 10, 2026, stating that Intersurgical Inc. is removing certain 22mm Smoothbore breathing tubes and systems. The Center for Devices and Radiological Health described it as a potentially high-risk device issue and said the agency will update the page as significant new information becomes available. The alert was published at 1:53 p.m. on November 10.
The agency said Intersurgical has issued a letter to affected customers recommending that certain breathing systems be removed from where they are used or sold. Affected products include model 5018000, a 22mm Smoothbore tube with soft end connectors, 22F to 22F, at least 1.8 meters, with lot 32511811 listed in the alert product table.
The stated reason is that tetrahydrofuran solvent is used in manufacturing to bond the soft connectors onto the tube, and connectors may detach. The tubes and systems connect patients to machines that help them breathe, and detachment can cause ventilation loss and may cause brain damage or death, according to the alert summary.
The recommended action is to immediately stop using and quarantine affected lots and return affected product to Intersurgical. The company sent the letter to all affected customers on November 3, 2026. As of November 3, Intersurgical had reported no serious injuries or deaths associated with this issue.
Customers in the United States with adverse reactions, quality problems or questions may contact Intersurgical Customer Service at [email protected] or 800-828-9633, as listed in the alert. This report covers only the facts and contact resources in the agency alert and makes no individual treatment recommendation.
来源链接： https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-intersurgical-inc-removes-22mm-smoothbore-breathing-tubes-and-systems
发布：GSM·美国（发布链接）
图片来源：食品药品监督固定图库（GSM asset-packs）
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