CAREFUSION

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
3
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1759-2022Class IIBD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171August 1, 2022
Z-1758-2022Class IIBD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166August 1, 2022
Z-1760-2022Class IIBD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433August 1, 2022
Z-1752-2022Class IIBD MaxGuard Extension Set with 4-way stopcock, REF: M4058August 1, 2022
Z-1757-2022Class IIBD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059August 1, 2022
Z-1754-2022Class IIBD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106August 1, 2022
Z-1756-2022Class IIBD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removablAugust 1, 2022
Z-1753-2022Class IIBD MaxGuard Extension Set, REF: ME1069August 1, 2022
Z-1755-2022Class IIBD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141August 1, 2022
Z-2468-2021Class IIBD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check ValvAugust 2, 2021
Z-2456-2021Class IIBD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031August 2, 2021
Z-2461-2021Class IIBD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, RAugust 2, 2021
Z-2467-2021Class IIBD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP ExtensionAugust 2, 2021
Z-2465-2021Class IIBD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006August 2, 2021
Z-2459-2021Class IIBD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmaAugust 2, 2021
Z-2454-2021Class IIBD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019EAugust 2, 2021
Z-2464-2021Class IIBD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006August 2, 2021
Z-2463-2021Class IIBD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BAugust 2, 2021
Z-2455-2021Class IIBD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7DAugust 2, 2021
Z-2458-2021Class IIBD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163EAugust 2, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K193088MaxZero Extension Sets with Needle-Free Connector(s)October 23, 2020
K153234AirLife Adult Heated Wire CircuitJuly 7, 2016
K151959AirLife Infant Single Limb Heated Wire CircuitJanuary 20, 2016