ClearanceBrief
Panels › General Hospital › Product code FPA · Class 2

Set, Administration, Intravascular

Regulation 880.5440

6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
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Top companies in FPA

DateFirm and productCodeLinked 510(k)
Apr 15, 2010Hospira Inc.
Latex-free, Primary I.V. Set, vented, 78 inch with injection site, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1881-48.
Terminated
FPANone listed
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line, Convertible Pin, 72 Inch with 2 Pressure-Activated Anti-Siphon Valve, CLAVE and OPTION-LOK for use OMNI-FLOW, a sterile
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with CLAVE and OPTION-LOK for use with OMNI-FLOW medication management system, 15 drops/mL,
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and Pressure-Activated Anti-Siphon Valve, convertible pin, 109 inch with CLAVE and OPTION-LOK for use OMNI-FLOW Medicati
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, convertible pin, 110 inch with high-pressure filter, orange polyethylene-lined/light
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, convertible pin, 110 inch with pre-pierced injection site and OPTION-LOK for use wit
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, convertible pin, 110 inch with inline cassette, collection bag, pre-pierced injection site and OPTION-LOK for use with
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with orange polyethylene-lined/light resistant tubing and
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prevention valve, convertible pin, 110 inch with secure lock for use with OMNI-FLOW medication management system,
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Latex-free, Primary I.V. Pump Set, convertible pin, 105 inch with 2 injection sites, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 3704-78.
Terminated
FPAK770087
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 103 inch with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL US
Terminated
FPAK052052
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, Primary I.V. PLUMSET, convertible pin, 113 inch with 2 pre-pierced injection sites and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Lifeshield, Primary I.V. Filter Set, yellow key slide clamp, backcheck valve, 2 CLAVE Y-sites, 0.2 micron filter, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Lifeshield, Primary I.V. Filter Set, yellow key slide clamp, backcheck valve, 2 CLAVE Y-sites, 0.2 micron filter, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Latex-free, Nitroglycerin Primary I.V. Pump Set, convertible pin, 107 inch with OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 1199
Terminated
FPAK821515
Apr 15, 2010Hospira Inc.
ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Purple striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use
Terminated
FPAK882594
Apr 15, 2010Hospira Inc.
ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Green striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use d
Terminated
FPAK882594
Apr 15, 2010Hospira Inc.
ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Orange striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use
Terminated
FPAK882594
Apr 15, 2010Hospira Inc.
Latex-free. Midlength Secondary I.V. Set, convertible pin, 40 inch with extension hook for use with OMNI-FLOW Medication Management System and PLUM Series Infusions Systems, 15 drops/mL, a sterile Rx
Terminated
FPAK832755
Apr 15, 2010Hospira Inc.
Latex-free, Nitroglycerin, Midlength Secondary I.V. Pump Set, convertible pin, 40 inch with orange polyethylene-lined/light resistant tubing low absorption secondary set. For use only with OMNI-FLOW a
Terminated
FPAK033576
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, HEMA, GEMSTAR, Y-Type Blood Pump Set, nonvented, 110 inch with CLAVE and OPTION-LOK, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Cost
Terminated
FPAK060806
Apr 15, 2010Hospira Inc.
Lifeshield, latex, free, GEMSTAR Primary Piggyback Pump Set-SL, convertible pin, attached pressure-activated anti-siphon valve, 110 inch with 2 CLAVE ports, 15 drops/mL, a sterile Rx single use device
Terminated
FPAK060806
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, MICRO-DRIP, SOLUSET, GEMSTAR 150 ml Burette Pump Set-OL, convertible pin, 110 inch, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa
Terminated
FPAK060806
Apr 15, 2010Hospira Inc.
Lifeshield, CVP Manometer, latex-free, Y-type primary IV set, nonvented, 86.5 inch with pre-pierced injection site, and OPTION-LOK, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Fores
Terminated
FPAK063239
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free 210 Micron Filter, Y-Type Blood Set, yellow key slide clamp, CLAVE Y-site, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, lis
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free 170 Micron Filter, Y-Type Blood Set, yellow key slide clamp, CLAVE Y-site, 10 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, lis
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with 2 CLAVE ports SOLUSET, MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL US
Terminated
FPAK063239
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, nonvented, 117 inch with pre-pierced injection site, ball check valve, backcheck valve, 2 CLAVE ports and removable 4-way high-flow stopcock and locking spi
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77.5 inch with 2 pre-pierced injection sites and OPTION-LOK, SOLUSET, MICRODRIP with, 60 drops/mL, a sterile Rx single use device, Hospira
Terminated
FPAK063239
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with capped port and CLAVE filter SOLUSET, MICRODRIP with OPTION-LOK, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lak
Terminated
FPAK063239
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 100 inch with 2 pre-pierced injection sites, SOLUSET, MICRODRIP, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL
Terminated
FPAK941214
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free 150 mL Burette IV Set, yellow key slide clamp, microdrip, CLAVE Y-site, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 2
Terminated
FPAK030002
Apr 15, 2010Hospira Inc.
Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced injection sites and OPTION-LOK MICRODRIP SOLUSET, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake F
Terminated
FPAK063239
Mar 30, 2010Arrow International Inc
Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lock SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM)
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable ad
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and Detachable 4-Way Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated Manifold Valve. (Approx. 10 Drops/ML); with Two Y-Injection Sites and Rotating Luer Lock (Approx. 10 Drop/ML); with
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for med
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang Pressure Activated Manifold Valve and Rotating Luer Lock End SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intra
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning Luerlock. DEHP-Free SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration T
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way Stopcock and Novex Stopcock. (Approx. 20 Drops/ML) SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Admi
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang Standard Bore Stopcocks and T-Connector SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tub
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard Bore Stopcocks and T-Connector. (Approx. 60 Drops/ML) SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and with 3-Gang 4-Way Stopcocks, Y-Injection Site and T-Connector. An Intravenous Administration Tubing set is a d
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and Luer Activated Y-Injection Sites. (Approx. 10 Drop/ML). An Intravenous Administration Tubing set is a device i
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM) Y-Injection sites and 4-Way Stopcock with Pressure Activated Valve Manifold. (Approx. 15 drops/ml). An Intravenous Administration Tu
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
IV Extension Set with Spike and 2-Way Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used t
Terminated
FPAK830755

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