The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2279-2013·Announced 2013-10-02

CareFusion Recalls SmartSite Infusion Sets Due to Incorrect Filter Assembly

CareFusion is recalling 600 units of SmartSite Low Sorbing Infusion Sets because an incorrect 0.2 micron filter may have been assembled instead of the required 1.2 micron filter.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves a component assembly error (incorrect filter micron rating) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

CareFusion 303, Inc. is recalling 600 units of the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314. These medical devices are used to administer fluids and medications through a needle or catheter inserted into a patient's artery or vein. The set includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.

The recall was initiated because an incorrect filter was assembled on this specific lot. The correct filter is a 1.2 micron filter (blue color), but a 0.2 micron filter (clear color) may have been added instead. This discrepancy affects the filtration capability of the device as intended.

The affected units were distributed to facilities in California, Florida, Arizona, and Tennessee. Healthcare providers and facilities should check their inventory for this specific model and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations, as directed by the recalling firm.

The recalled product

Product
SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Sets
Hazard
Affected units
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 Number 13016314

Distribution

Distributed in 4 states:

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