美国食品药品管理局11月9日将Cardinal Health Presource包更正定级为一级召回：涉及所含BD Alaris输液泵输液套件的使用说明更新，无需下架
华盛顿 — 美国食品药品管理局 11 月 9 日更新通告称，Cardinal Health 公司 Presource 便利包的使用说明更正已被定级为一级召回。该局说明，这类召回属于最严重类型，若不按更新后的说明继续使用相关器械，可能造成严重伤害或死亡；本次召回是更新使用说明，不涉及把产品从使用或销售地点移除。
受影响产品为含有 BD Alaris 输液泵输液套件的 Presource 包。Cardinal Health 已于 9 月 23 日致信受影响客户，说明某些 Presource 包含有受另一项 BD 输液套件召回影响的输液套件，并建议客户查阅 BD 客户函中的输液套件性能披露，据此调整临床使用、套件选择或泵的使用。
食品药品管理局转述 BD 的说明称，部分带有受限组件与设计的 Alaris 输液套件表现不如先前披露，尤其在每小时低于 1 毫升的低编程速率与 5 毫升及以下的推注量时更明显，先前宣称的性能被高估，在某些情况下输液表现明显更差，可能导致输注不足或过量、堵塞报警延迟与推注剂量不准。
通告特别指出，新生儿、儿科与重症等高风险人群更可能接受低速率或低容量输注，受影响程度可能更严重。截至 2026 年 8 月 19 日，BD 尚未报告与这一问题相关的严重伤害或死亡。
时间线方面，食品药品管理局于 10 月 20 日就这一潜在高风险器械问题发出早期警示，11 月 9 日更新通告告知公众该事项已定级为一级召回，受影响产品与建议做法没有改变。本稿只转述通告事实，不作个体诊疗建议。
FDA Classifies the Cardinal Health Presource Pack Correction as a Class I Recall on November 9: Updated Use Instructions for Contained BD Alaris Pump Infusion Sets, With No Removal From Use or Sale
Washington — The Food and Drug Administration updated its communication on November 9 to say the Cardinal Health Presource convenience pack correction has been classified as a Class I recall. The agency says this is the most serious type of recall, that the device may cause serious injury or death if used without following the updated instructions, and that this recall involves updating instructions and does not involve removing products from where they are used or sold.
The affected products are Presource kits containing BD Alaris Pump Infusion Sets. Cardinal Health sent a letter to affected customers on September 23 stating that certain Presource kits contain infusion sets affected by the BD infusion set recall, and recommending that customers review the pump infusion set performance disclosures in the BD customer letter and make any necessary adjustments to clinical use, set selection or pump use.
The FDA relays BD statement that some Alaris pump sets with restrictive components and designs perform worse than previously disclosed, most commonly at low programmable rates under 1 milliliter per hour and at or under 5 milliliters of bolus volume, that previously claimed performance was overestimated and in some instances is significantly worse, with the potential for under or over infusion, delayed time to occlusion alarms and bolus dose inaccuracies.
The communication notes that neonates, pediatrics and critically ill patients are higher risk populations more likely to receive lower rate or lower volume infusions. As of August 19, 2026, BD had not reported any serious injuries or deaths associated with this issue.
On the timeline, the FDA issued an Early Alert on October 20 about the potentially high risk device issue, and updated the communication on November 9 to inform the public that the issue has been classified as a Class I recall, with the affected products and recommendations unchanged. This report relays only the facts in the communication, without individual treatment advice.
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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