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) |
|---|---|---|---|
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic fluid pathway, 8'', 0.22 mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60 Terminated |
FPA | K811078 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerf Terminated |
FPA | K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22'', 0.9 mL Vol, with injection site and Stationary Swivel Lock T-Connector; Baxter H Terminated |
FPA | K921899 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8483; An Rx sterile, nonpyrogenic fluid pathway, 18', 1.3 mL Vol. with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Terminated |
FPA | K964850 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Exte Terminated |
FPA | K925126 K964850 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Terminated |
FPA | K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pathway, 13.0'', 0.4 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U. Terminated |
FPA | K811078 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter; Baxter Healthcare Terminated |
FPA | K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter Health Terminated |
FPA | K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Anesthesia Set, product code 2C9216; An Rx sterile, nonpyrogenic fluid pathway, 72'', 1.7 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FPA | K880733 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyrogenic fluid pathway, 61'', 0.9 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, I Terminated |
FPA | K811078 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer Lock adapter with Re Terminated |
FPA | K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FPA | K811463 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60'', 0.5mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6 Terminated |
FPA | K811463 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.38mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FPA | K811463 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites and male Luer Lock Terminated |
FPA | K921899 K925126 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a male Luer Lock adapt Terminated |
FPA | K791496 K915390 +1 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.3 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, Terminated |
FPA | K811078 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pathway, 6.4'', 0.4 mL Vol., with male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | K811078 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, Terminated |
FPA | K791496 |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 1.0 mL Vol., with 2 Luer Activated Valves and a male Luer Lock ad Terminated |
FPA | K003225 |
| Mar 18, 2006 | Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, n Terminated |
FPA | K811933 K991599 |
| Mar 18, 2006 | Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, Terminated |
FPA | K811933 K991599 |
| Mar 18, 2006 | Smiths Medical MD, Inc. Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary ( Terminated |
FPA | K811933 K991599 |
| Feb 8, 2006 | Hospira Inc. Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, Hospira, Inc., Lake F Terminated |
FPA | K813464 K831506 |
| Feb 8, 2006 | Hospira Inc. LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A. Terminated |
FPA | K832755 |
| Feb 8, 2006 | Hospira Inc. Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A. Terminated |
FPA | K830014 |
| Nov 26, 2005 | Baxter Healthcare Corp. Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Baxter Healthcare Corporation, Deerfield, Terminated |
FPA | K984381 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3716; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1-1/2'', Total Volum Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3714; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 1'', Total Volume 0. Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1'', Total Volume 0. Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3710; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1'', Total Volume 0. Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 3/4'', Total Volume Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3707; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 3/4'', Total Volume Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3706; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 3/4'', Total Volume Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Huber Needle Extension Set, product code 2N3703; An Rx sterile, nonpyrogenic fluid pathway with Needle Gauge 22, Needle Length 3/4'', Total Volume 0.40 mL, Total Length 9''; Ba Terminated |
FPA | K961495 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway, 61'', 1.4 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FPA | K880733 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Tamper Resistant Anti-Siphon Combination Set, 101'', product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101'', 2.5 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporati Terminated |
FPA | K840760 K880733 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 96'', product code 2C9206; An Rx sterile, nonpyrogenic fluid pathway, 96'', 1.6 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Terminated |
FPA | K880733 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60'', product code 2C9205; An Rx sterile, nonpyrogenic fluid pathway, 60'', 1.2 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Terminated |
FPA | K880733 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Mini-Infuser Microbore Extension Set, product code 2C9201; An Rx sterile, nonpyrogenic fluid pathway, 61'', 0.5 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60 Terminated |
FPA | K860272 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, 36'', product code 2C5685; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.9 mL Vol., with a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60 Terminated |
FPA | K860272 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Minivolume Extension Set, 72'', product code 2C5687; An Rx sterile, nonpyrogenic fluid pathway, 72'', 1.6 mL Vol., with a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60 Terminated |
FPA | K860272 |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Terminated |
FPA | K791496 K925126 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FPA | K791496 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | K925126 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporat Terminated |
FPA | K811078 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter Terminated |
FPA | K964850 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A Terminated |
FPA | K925126 |
| Aug 6, 2005 | Baxter Healthcare Corp. Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico Terminated |
FPA | K002679 |
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