FDA (Devices) recall action 88203

CAREFUSION recalled 15 products on 2021-09-22

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products: 15
Announced: 2021-09-22
Critical: 0
Units: 49,562,352

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–15 of 15

HighFDA (Devices)··2021-09-22
BD SmartSite Needle-Free Connector Valves Recalled for Flow and Occlusion Issues
CAREFUSION is recalling BD SmartSite needle-free connector valves due to difficulty flushing, flow issues, and occlusions that could delay therapy. Approximately 23.8 million units were distributed worldwide.
Product
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
Extension Set SMALLBORE Tubing with SmartSite Valves Recalled for Flushing Issues
BD Extension Set SMALLBORE Tubing with SmartSite Valves (REF: 20019E) is being recalled due to flushing difficulties, flow issues, and occlusions that could delay therapy. Over 1.4 million units distributed worldwide are affected.
Product
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD SmartSite Bag Access Device Recalled for Valve Occlusion Issues
CAREFUSION is recalling BD SmartSite Bag Access Device needle-free connector valves due to potential occlusions and flow issues that could delay therapy delivery.
Product
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD needle-free connector valves may occlude or restrict fluid flow
BD Burette Gravity Set needle-free connector valves may fail to flush or develop blockages, potentially delaying patient therapy. Lot 21015553 consists of approximately 630 units distributed worldwide.
Product
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD Gravity Burette Set Needle-Free Connector Valves Recalled for Flow Issues
CAREFUSION is recalling BD Gravity Burette Sets with needle-free connector valves that may develop flow restrictions and blockages, potentially delaying medication delivery. Approximately 29,130 units were distributed.
Product
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD Needle-Free Bag Access Valves Recalled for Flow Obstruction
BD SmartSite needle-free valves may become obstructed, preventing proper fluid flow in medical infusions. The FDA recalls over 295,000 units due to risk of therapy delays.
Product
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD needle-free connector valves recalled for flow obstruction risk
BD needle-free connector valves and extension sets may experience flow obstruction and flushing difficulties, potentially delaying medical therapy. No adverse events have been reported.
Product
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 VALV
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD SmartSite Needle-Free Valve Extension Set Recalled for Potential Occlusion
CareFusion recalls BD SmartSite needle-free valve extension sets due to potential occlusion, flow issues, and difficulty flushing that could delay medical therapy.
Product
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Category
Distribution
53 states
HighFDA (Devices)··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.
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
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD Alaris Infusion Pump Buerette Sets Needle-Free Connector Valve Issues
BD Alaris Pump Infusion Buerette Sets with needle-free connector valves may experience flushing difficulties, flow issues, or occlusions that could delay therapy delivery. No illnesses or injuries have been reported.
Product
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Bue
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD Gravity IV needle-free connector valve occlusion risk
BD Gravity IV needle-free connector valves may develop flow issues and partial or total occlusions that could delay therapy. The recall affects 24,360 units distributed worldwide.
Product
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & Smar
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
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.
Product
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD Syringe Set Needle-Free Connector Valves May Cause Therapy Delay
BD Syringe Set needle-free connector valves may experience difficulty flushing, flow issues, or occlusions that could delay patient therapy. About 16,700 units have been distributed worldwide.
Product
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TBG CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798703;
Category
Distribution
53 states
HighFDA (Devices)··2021-09-22
BD Alaris Infusion Pump Buerette Set Connector Valve Occlusion Issues
BD Alaris needle-free connector valves in Buerette Sets may develop occlusions, difficulty flushing, or flow issues that could delay patient therapy. The product was distributed worldwide across all US states and multiple countries.
Product
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Category
Distribution
53 states
HighFDA (Devices)··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.
Product
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
Category
Distribution
53 states