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.
Published by GSM · USA (original Chinese edition)
Photo: 食品药品监督固定图库（GSM asset-packs）
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