Agency classClass IIOur severity:High FDA (Devices)·Z-2467-2021·Announced 2021-09-22

BD SmartSite Needle-Free Connector Valves Recalled for Flow and Occlusion Issues

CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.

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: This is an FDA Class II recall of a medical device used for drug and fluid delivery. The recalled devices may experience occlusions and flow issues that could delay therapy, but no illnesses or injuries have been reported, meeting the criteria for High severity as a risk-of-harm product without reported injury.

Plain-English summary

BD SmartSite needle-free connector valves are being recalled by CAREFUSION due to potential flushing difficulties, flow issues, and partial or total occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide, including throughout the United States and to Canada, New Zealand, Taiwan, Australia, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil.

The devices may experience functional issues that could affect medication or treatment delivery through the valve system, potentially delaying the administration of therapy to patients.

According to the FDA recall notice, follow-up actions are not required for products that have already been safely used or connected to the connecting device.

The recalled product

Product: BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF…
Manufacturer: CAREFUSION
Category: Medical Device — Infusion Connector Valve
Hazard: occlusion
flow-obstruction
therapy-delay
Affected units: 23,786,178

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 · occlusion