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.
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 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: 20038E7D
- Manufacturer
- CAREFUSION
- Hazard
- occlusion
- flow-obstruction
- therapy-delay
Distribution
Distributed nationwide across the United States.
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