CareFusion Recalls SmartSite Add-On Bag Access Device Due to Leakage
CareFusion is recalling 384,923 units of the SmartSite Add-On Bag Access Device because the spike port may separate or leak, potentially interrupting medication infusion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential exposure to hazardous infusates and interruption of medication, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling 384,923 units of the SmartSite Add-On Bag Access Device, Model No. 10013365. The recall was initiated due to reports of separation and/or leakages between the spike port and the drip chamber spike.
The affected devices were distributed across the United States. The specific lot codes involved in this recall are: 15055146, 15055702, 15056299, 15056618, 15065645, 15075740, 15076166, 15076167, 15076664, 15076729, 15077085, 15085031, 15085156, 15086107, 15095014, 15095411, 15106928, 15116928, 15125952, 15126069, 15127413, 16015324, 16015325, 16015607, 16025824, 16025948, 16027008, 16035527, and 16036131.
A separation or leak in the device can cause a delay or interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. Healthcare providers and facilities should check their inventory for these specific lot codes and stop using affected units. Consumers should contact their healthcare provider if they have questions about this recall.
The recalled product
- Product
- SmartSite Add-On Bag Access Device, Model No. 10013365
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 384,923
Distribution
Distribution scope not specified by the agency.
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