ClearanceBrief
Company ยท US

CAREFUSION

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2020. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
31recalls (0 in 12 months)
29recalls that name a 510(k)

Product codes

CodeDeviceRecords
FPASet, Administration, Intravascular26
FRNPump, Infusion4
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer2
BRYCabinet, Table And Tray, Anesthesia1
GWQFull-Montage Standard Electroencephalograph1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 23, 2020K193088MaxZero Extension Sets with Needle-Free Connector(s)
Carefusion, Inc.
FPA
Jul 7, 2016K153234AirLife Adult Heated Wire Circuit
Carefusion, Inc.
BZE
Jan 20, 2016K151959AirLife Infant Single Limb Heated Wire Circuit
Carefusion, Inc.
BZE

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 13, 2022CAREFUSION
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set, REF: ME1069
Open, Classified
FPAK051499
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Open, Classified
FPAK051499
Aug 2, 2021CAREFUSION
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
Open, Classified
FPAK970485
Aug 2, 2021CAREFUSION
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 Lue
Open, Classified
FPAK960280
Aug 2, 2021CAREFUSION
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Open, Classified
FPAK960280
Aug 2, 2021CAREFUSION
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
Open, Classified
FPAK931550
Aug 2, 2021CAREFUSION
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
Open, Classified
FPAK780130
Aug 2, 2021CAREFUSION
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: CS42522
Open, Classified
FPAK931173
Aug 2, 2021CAREFUSION
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Open, Classified
FPAK951922
Aug 2, 2021CAREFUSION
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Open, Classified
FPAK970485
Aug 2, 2021CAREFUSION
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: 10010
Open, Classified
FPAK960280
Aug 2, 2021CAREFUSION
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 Smart
Open, Classified
FPAK944320
Aug 2, 2021CAREFUSION
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Open, Classified
FPAK820278
Aug 2, 2021CAREFUSION
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;
Open, Classified
FPAK811885
Aug 2, 2021CAREFUSION
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 ,
Open, Classified
FPAK780130
Aug 2, 2021CAREFUSION
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Open, Classified
FPAK061285
Aug 2, 2021CAREFUSION
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Open, Classified
FPAK061285
Jun 9, 2021CAREFUSION
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiratio
Terminated
FPANone listed
Apr 15, 2013Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Terminated
FRNK051641
Apr 15, 2013Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Terminated
FRNK051641
Mar 28, 2013CareFusion Corporation
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist a
Terminated
BRYNone listed
Oct 13, 2010CareFusion Corporation
CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009
Terminated
FRNK051641
Aug 2, 2010CareFusion Corporation
Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module
Terminated
FRNK051641
Apr 7, 2010CareFusion
NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.
Terminated
GWQK991054
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