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)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2010 | Hospira 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 |
FPA | None listed |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K770087 |
| Apr 15, 2010 | Hospira 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 |
FPA | K052052 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K821515 |
| Apr 15, 2010 | Hospira 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 |
FPA | K882594 |
| Apr 15, 2010 | Hospira 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 |
FPA | K882594 |
| Apr 15, 2010 | Hospira 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 |
FPA | K882594 |
| Apr 15, 2010 | Hospira 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 |
FPA | K832755 |
| Apr 15, 2010 | Hospira 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 |
FPA | K033576 |
| Apr 15, 2010 | Hospira 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 |
FPA | K060806 |
| Apr 15, 2010 | Hospira 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 |
FPA | K060806 |
| Apr 15, 2010 | Hospira 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 |
FPA | K060806 |
| Apr 15, 2010 | Hospira 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 |
FPA | K063239 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K063239 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K063239 |
| Apr 15, 2010 | Hospira 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 |
FPA | K063239 |
| Apr 15, 2010 | Hospira 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 |
FPA | K941214 |
| Apr 15, 2010 | Hospira 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 |
FPA | K030002 |
| Apr 15, 2010 | Hospira 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 |
FPA | K063239 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
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