Carefusion FDA Recalls

25 recalls on file across devices, 0 of them Class I and 24 still open. Matched by name to CFN.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Extension Set, REF: ME1069Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REClass IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106Class IIAug 1, 2022Administration set, and extension set product labels list ex	Administration set, and extension set product labels list expiration year 2027 but the labels should list expi	Class IIDevices	Aug 1, 2022
BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7DClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019EClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-pClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: Class IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564Class IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006Class IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006Class IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle FreeClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC TClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free VaClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10Class IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity BuretteClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006Class IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309EClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163EClass IIAug 2, 2021Needle-free connector valves, either standalone or attached	Needle-free connector valves, either standalone or attached to extension sets, may have issues including diffi	Class IIDevices	Aug 2, 2021
MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be useClass IIJun 9, 2021A portion of a validation lot was inadvertently released to	A portion of a validation lot was inadvertently released to the US Market. The product did not meet the valid	Class IIDevices	Jun 9, 2021