CAREFUSION Recalls
28 recalls on record · April 3, 2013 to September 28, 2022 · Medical Devices
Recalls by year
13
21
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, RE
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Extension Set, REF: ME1069
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 28, 2022Medical DevicesFDA
CAREFUSION recalls BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Hazard: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Va
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVented, REF: 72103E-0006
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-0006
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-p
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF:
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Syringe Set 20 DP MIC TBG 0.2MF CKV Anti-Siphon SmartSite VLV Sensing Disc, REF: 10798696; BD Syringe Set 20 DP MIC T
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD SmartSite 'Y' Extension Set 2 Needle-Free Valves, REF: 20019E7D
Hazard: 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.
September 22, 2021Medical DevicesFDA
CAREFUSION recalls BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E
Hazard: 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.
July 7, 2021Medical DevicesFDA
CAREFUSION recalls MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be use
Hazard: A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
April 24, 2013Medical DevicesFDA
Carefusion Corporation recalls Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming,
Hazard: The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
April 24, 2013Medical DevicesFDA
Carefusion Corporation recalls Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, m
Hazard: The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
April 3, 2013Medical DevicesFDA
CareFusion Corporation recalls Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing d
Hazard: The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.