Extension Set SMALLBORE Tubing with SmartSite Valves Recalled for Flushing Issues
BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.
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 recall with no reported illnesses or injuries. The hazard—flushing difficulties and occlusions causing potential therapy delay—is a real device malfunction but theoretical harm. Per the rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES (REF: 20019E), manufactured by CAREFUSION, is being recalled due to potential functional issues with the needle-free connector valves.
The recalled device may experience difficulty flushing, flow issues, and partial or total occlusions. These malfunctions could lead to delays in medical therapy delivery.
Approximately 1,463,647 units have been distributed worldwide, including across all U.S. states and territories, as well as to Canada, New Zealand, Australia, Taiwan, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, the Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, and Brazil. Specific lot numbers affected are documented by the FDA.
Healthcare providers and patients should not use devices from the recalled lots. However, if a device from a recalled lot has already been used or was safely connected to a female luer, no further action is needed. For additional information, contact the manufacturer or the FDA.
The recalled product
- Product
- BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
- Manufacturer
- CAREFUSION
- Hazard
- occlusion
- flushing-difficulty
- flow-obstruction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 27613203013813
Distribution
Distributed nationwide across the United States.
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