BD SE Burette Set needle-free connectors recalled for flow obstruction risk
CareFusion is recalling BD SE Burette Sets with needle-free connector valves that may fail to flush or develop flow obstructions, risking therapy delays. Approximately 56,680 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: FDA Class II recall of a medical device with potential for therapy delay due to valve malfunction. No injuries or illnesses are reported in the source text, and the hazard is functional rather than immediately life-threatening, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion is recalling the BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented (REF: 72103E-0006), an infusion device with needle-free connector valves. Approximately 56,680 units of this product have been distributed worldwide.
The needle-free connector valves in these sets may experience difficulty flushing, flow issues, and partial or total occlusions. These defects could lead to therapy delays during medical treatment.
The affected units were distributed to healthcare facilities nationwide in the United States and to multiple countries including Canada, New Zealand, Taiwan, Australia, Belgium, Vietnam, Argentina, Malaysia, Thailand, South Korea, Indonesia, Philippines, Singapore, Bahrain, Saudi Arabia, Hong Kong, India, China, Brazil, and others. Sixteen specific lot numbers have been identified as affected.
Patients and healthcare providers should check if infusion sets from the recalled lots are being used. If a set has already been used or safely connected, follow-up activation is not required. Healthcare providers should contact CareFusion or the FDA for additional guidance if unused recalled devices are discovered.
The recalled product
- Product
- BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
- Manufacturer
- CAREFUSION
- Category
- Medical Device — Infusion Set
- Hazard
- flow-obstruction
- occlusion
- therapy-delay
Distribution
Distributed nationwide across the United States.
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