The Recall Desk
HighFDA (Devices)·Z-2464-2021·Announced 2021-09-22

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.

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 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
Hazard
  • occlusion
  • flow-obstruction
  • therapy-delay

Distribution

Distributed nationwide across the United States.

Related recalls

Same category