CareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter
CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.
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 involves a medical device with a labeling omission that creates a risk of harm (filter occlusion) if used for blood administration, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the SmartSite Low Sorbing Infusion Set, Model Codes 10014855A, 10015861A, 10061661A, 14035457, 14035485, 14046894, and 14035458. The recall involves 5,600 units distributed in Florida, New Mexico, Washington, Wisconsin, and Texas.
The recall was initiated because the infusion sets were assembled with a drip chamber containing a 15-micron filter. The Directions For Use did not indicate the presence of this filter and failed to instruct users not to use the set for blood administration. Using the set with blood could potentially occlude the 15-micron filter in the drip chamber.
Healthcare facilities and consumers should stop using the affected infusion sets and contact CareFusion 303, Inc. for further instructions or a replacement.
The recalled product
- Product
- SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Set
- Affected units
- 5,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 14035485 14046894 14035458 14035457
Distribution
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