BD SmartSite Bag Access Device Recalled for Valve Occlusion Issues
CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.
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: Class II medical device recall with no reported illnesses or injuries. The defect creates risk of therapy delay through device occlusion or flow impairment, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported. Per the rubric, theoretical hazards with no reported harm are scored at most 3.
Plain-English summary
CAREFUSION is recalling the BD SmartSite Bag Access Device and BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE (REF: 2300E-0500 and 2309E) due to potential issues with the needle-free connector valves. The affected valves may experience difficulty flushing, reduced flow, or partial to total occlusions that could lead to delays in therapy delivery.
Approximately 708,910 units have been distributed worldwide. The affected lot numbers were distributed to healthcare facilities across the United States in all 50 states, Puerto Rico, Guam, and the District of Columbia. International distribution includes Canada, Australia, New Zealand, Taiwan, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil.
Healthcare providers and patients should monitor for signs of device occlusion or reduced flow. If a device has already been used or was safely connected without complications, no further action is required. Healthcare facilities should assess any devices that have not yet been used for potential valve malfunction and contact CAREFUSION regarding product replacement or additional guidance.
This is a Class II recall. For additional information, contact CAREFUSION or visit the FDA website.
The recalled product
- Product
- BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
- Manufacturer
- CAREFUSION
- Affected units
- 708,910
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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