Agency classClass IIOur severity:High FDA (Devices)·Z-2460-2021·Announced 2021-09-22

BD needle-free connector valves recalled for flow obstruction risk

BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. Occlusions and flow obstruction in IV therapy connectors represent a risk-of-harm to therapy delivery. Per FDA rubric, such recalls without reported adverse events score as High (3).

Plain-English summary

BD (CareFusion) is recalling multiple models of needle-free connector valves and extension sets featuring SmartSite valves. Approximately 20.8 million units have been distributed worldwide and across the United States.

The recalled valves may experience difficulty flushing, flow issues, and partial or total occlusions. These conditions could delay therapy delivery. No patient injuries or adverse events have been reported.

Healthcare facilities and consumers using affected products should verify proper function. The FDA states that follow-up is not required if the device has already been used or was properly connected to the female luer of the connecting device. Detailed lot numbers are provided in FDA recall notice Z-2460-2021.

The recalled product

Product: BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL…
Manufacturer: CAREFUSION
Category: Medical Device — Infusion therapy connectors
Hazard: flow-obstruction
flushing-difficulty
occlusion
Affected units: 20,874,700

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 15 recalled by CAREFUSION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Same manufacturer · CAREFUSION

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Same hazard · flow obstruction