Medline麻醉回路套件Class 1召回：编号Z-0449-2026涉两个批次
美国食品药品管理局（FDA）器械召回数据库于2025年11月13日公布一条Class 1器械召回，召回编号为Z-0449-2026，召回事件编号97882，召回企业为位于伊利诺伊州Northfield的Medline Industries, LP。涉事产品为麻醉回路套件，产品代码DYNJAA10230，涉及批次25EBV570与25FBT843，企业于2025年10月10日启动召回。
FDA记录显示，企业收到多起关于120英寸可伸缩管路出现裂纹、导致麻醉回路泄漏的投诉。记录称，裂纹与泄漏可能导致缺氧、通气不足以及吸入麻醉剂输送不足，可能造成严重伤害或死亡。FDA认定的召回原因为材料或部件不合格。
企业已于10月10日向客户发出安全通知，并于10月21日发出后续的紧急医疗器械召回通知，通过电子邮件与一等邮件送达。通知要求客户立即检查库存中受影响的产品与批次，隔离全部受影响产品并就地销毁，不得退回Medline；分销商或已转售、转让该产品的机构，须按FDA规定通知下游接收方。
FDA Database Posts Class 1 Recall of Medline Anesthesia Circuit Kits on November 13, Recall Z-0449-2026 Covering Two Lots
The U.S. Food and Drug Administration (FDA) device recall database posted a Class 1 device recall on November 13, 2025, numbered Z-0449-2026 under recall event 97882, naming Medline Industries, LP of Northfield, Illinois, as the recalling firm. The product is an anesthesia circuit kit, product code DYNJAA10230, covering lots 25EBV570 and 25FBT843. The firm initiated the recall on October 10, 2025.
According to the FDA record, the firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120-inch expandable tubing. The record states that the cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. The FDA-determined cause is listed as a nonconforming material or component.
The firm provided a safety notice to customers on October 10 and a follow-up urgent medical device recall notification dated October 21, sent by email and first-class mail. Customers were instructed to immediately check stock for the affected item and lot numbers, quarantine all affected product, and destroy affected kits on hand; no products are to be returned to Medline. Distributors and others who resold or transferred the product are required under FDA regulations to notify recipients of the recall.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：美国海军医护人员对野战麻醉设备进行系统检查，该设备包含麻醉呼吸回路。照片：美国海军 Bernardo Fuller，公共领域，经 Wikimedia Commons / U.S. Navy personnel perform a systems check on a field anesthesia machine with a breathing circuit. Photo: U.S. Navy, public domain, via Wikimedia Commons
GSM Global · 本篇英文版 English edition of this story
