Needle-Free Burette Set Valves Recalled for Occlusion and Flow Issues
BD ADD-ON Burette Set V/NV Needle-Free Valves may experience occlusions or flow issues that could delay therapy. CAREFUSION recalled 44,120 units with this defect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential for therapy delay due to occlusion and flow issues; no illnesses or injuries are reported in the source, limiting severity to High per the rubric.
Plain-English summary
BD ADD-ON Burette Set V/NV Needle-Free Valves (REF: 82113E-0006) manufactured by CAREFUSION may have difficulty flushing, flow issues, or partial to total occlusions. These defects could lead to therapy delays.
The recall affects 44,120 units distributed worldwide, including throughout the United States and several international locations. Affected lot numbers have been identified and should be checked against current inventory.
Healthcare providers and patients currently using these devices should monitor for occlusion or flow problems. Products already safely used or connected do not require follow-up action.
The recalled product
- Product
- BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
- Manufacturer
- CAREFUSION
- Category
- Medical Device — Infusion Set
- Affected units
- 44,120
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.
See all 15 products in this recall →Related recalls
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