BD Needle-Free Bag Access Valves Recalled for Flow Obstruction
BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.
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: FDA Class II medical device recall with confirmed flow obstruction and occlusion defects that could delay therapy delivery, but no reported injuries or adverse events. Meets criteria: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
CAREFUSION is recalling BD SmartSite Bag Access Device Needle-Free Valves (REF: 2300E and 2309E-0006) after identifying potential defects affecting approximately 295,331 units worldwide. Affected devices are identified by specific lot numbers listed in the FDA alert.
The recalled needle-free connector valves may experience difficulty flushing, flow issues, or partial to complete blockage. These malfunctions could delay medical therapy delivery, potentially affecting patient care.
The devices have been distributed nationwide in all 50 U.S. states, plus Puerto Rico, Guam, and the District of Columbia, as well as internationally to multiple countries including Canada, Australia, China, India, and others.
The FDA states that no follow-up action is necessary for devices that have already been used or that were safely connected. If you have unused affected devices, contact CAREFUSION or your healthcare provider for guidance on whether replacement is needed. Check the lot numbers on your devices against the list provided by the FDA.
The recalled product
- Product
- BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
- Manufacturer
- CAREFUSION
- Affected units
- 295,331
Distribution
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.
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