The Recall Desk
HighFDA (Devices)·Z-2455-2021·Announced 2021-09-22

BD SmartSite Needle-Free Valve Extension Set Recalled for Potential Occlusion

CareFusion recalls BD SmartSite needle-free valve extension sets due to potential occlusion, flow issues, and difficulty flushing that could delay medical therapy.

What this means for you

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: This is an FDA Class II recall of a medical device with potential for therapy interruption due to occlusion or flow failure, with no reported injuries or deaths. The hazard qualifies as a risk-of-harm product without reported injury, warranting a High severity classification per the rubric.

Plain-English summary

BD SmartSite 'Y' Extension Set 2 Needle-Free Valves (Reference 20019E7D), manufactured by CareFusion, have been recalled due to potential issues with the needle-free connector valves. The valves may experience difficulty flushing, flow obstruction, or partial or total occlusion that could lead to therapy delay.

The recalled products were distributed worldwide and throughout the United States. The specific lot numbers affected by the recall have been identified by the FDA and are available in the recall documentation.

No follow-up action is required if the product has already been used or was successfully connected to the female luer of a connecting device.

The recalled product

Product
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Manufacturer
CAREFUSION
Category
Medical Device — Needle-Free Valve
Hazard
  • occlusion
  • flow-obstruction
  • flushing-difficulty

Distribution

Distributed nationwide across the United States.

Related recalls

Same category