Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BD Extension Set SMALLBORE Tubing SmartSite VALVE Recalled by CAREFUSION Due to Needle-free connector valves, either standalone or attached to...

Date: August 2, 2021
Company: CAREFUSION
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact CAREFUSION directly.

Affected Products

BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010983; BD Gravity Burette Set 60 DP 4 VersaSafe PORTS 3 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10011087; BD EXTENSION SET SMALLBORE TUBING SmartSite VALVE (DETACHABLE), REF: 10011253; BD EXTENSION SET LOW SORBING TUBING 0.2 MICRON FILTER SmartSite VALVE, REF: 10013902; BD EXTENSION SET 2 SmartSite VALVES Y-CONNECTOR, REF: 10014692; BD EXTENSION SET SMALLBORE TUBING 2 DETACHABLE SmartSite VALVES, REF: 10015488; BD SmartSite NEEDLE FREE VALVE, REF: 2000E; BD Extension Set J-LOOP SMALLBORE Tubing SmartSite VALVE, REF: 20021E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20035E; BD Extension Set SMALLBORE Tubing SmartSite VALVE SLIP LUER, REF: 20037E; BD Extension Set TRI-PORT SMALLBORE Tubing 3 SmartSite VALVES, REF: 20038E; BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 20039E; BD Extension Set SmartSite VALVE SLIP LUER, REF: 20057E; BD Extension Set SmartSite VALVE, REF: 20059E; BD extension Set Y-CONNECTOR 2 SmartSite VALVES, REF: 20061E; BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite VALVES, REF: 20062E; BD EXTENSION SET Y-CONNECTOR 2 SmartSite VALVE, REF: 20159E; BD Extension Set TRI-PORT SMALLBORE TUBING SmartSite VALVE DETACHABLE, REF: 20338E; BD EXTENSION SET SmartSite VALVE, REF: 21059E; BD 8.5-IN PRESSURE RATED EXTENSION SET SmartSite VALVE, REF: 22003E-07; BD Texium SmartSite VALVE MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T; BD EXTENSION SET SmartSite VALVE (DETACHABLE), REF: 22059E; BD EXTENSION SET SmartSite VALVE (DETACHABLE) SLIP LUER, REF: C25015E; BD SmartSite Syringe-Syringe Transfer Device, REF: MV0450

Quantity: 20,874,700

Why Was This Recalled?

Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CAREFUSION

CAREFUSION has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report