The Recall Desk
HighFDA (Devices)·Z-2456-2021·Announced 2021-09-22

FDA recalls BD burette sets for connector valve occlusion and flow defects

BD Gravity Burette Sets and Add-On Burette Sets are being recalled due to needle-free connector valve defects that may cause flushing difficulties, flow problems, or complete occlusions, potentially delaying therapy. The recall affects approximately 77,802 units 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: This is a risk-of-harm medical device recall where the hazard—valve occlusion and flow obstruction—is specific and could impair therapy delivery. However, no patient injuries, hospitalizations, or deaths have been reported. Per the rubric, risk-of-harm products without reported injury score at 3, and the absence of reported harm prevents a higher classification despite the potential consequences.

Plain-English summary

BD Gravity Burette Sets and Add-On Burette Sets with needle-free connector valves are subject to this FDA recall. The affected products include BD Gravity Burette Sets (reference numbers 10037031, 10037032) and Add-On Burette Sets (reference numbers 82104E, 82113E, 82114E, 82115E), manufactured by CareFusion. Approximately 77,802 units have been distributed.

The needle-free connector valves in these products may experience defects that cause difficulty flushing, flow issues, or partial to total occlusions. These problems could lead to delays in therapy delivery.

The affected products have been distributed worldwide, including all U.S. states and territories as well as multiple international countries.

Healthcare facilities and providers should identify affected products using the provided lot numbers and contact CareFusion or their supplier. No additional action is required if the product has already been used without incident or was safely connected. Any concerns about product performance should be reported to the manufacturer.

The recalled product

Product
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAM
Manufacturer
CAREFUSION
Category
Medical Device — Infusion Sets and Burettes
Hazard
  • occlusion
  • flow-obstruction
  • connector-malfunction

Distribution

Distributed nationwide across the United States.

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Same category