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 19, 2012 | Medtronic MiniMed Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm) Terminated |
FPA | K030149 |
| Jan 19, 2012 | Hospira Inc. Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Terminated |
FPA | K101677 |
| Jan 17, 2012 | Smiths Medical ASD, Inc. CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to Terminated |
FPA | K991301 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 60 Drops/cc, 84 length, Catalog/REF No. P-S2V-60 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 60 Drops/cc, 84" length, Catalog/REF No. P-S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, U Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 52 Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, U Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free), 12 length, Catalog/REF No. P-S2-12 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 135 Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- Th Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF No. S2-20 MD, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a dis Terminated |
FPA | K905498 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- Th Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 in. length, Catalog/REF No. S2-12N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disp Terminated |
FPA | K964844 |
| Jan 11, 2012 | ConMed Corporation STAT 2 Extension Set Gravity Flow Controller, 12 in. length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device w Terminated |
FPA | K964844 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter, Length 95" (2.4 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for t Terminated |
FPA | K932301 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length 86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the Terminated |
FPA | K932301 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the Terminated |
FPA | K961225 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration Terminated |
FPA | K940867 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the pati Terminated |
FPA | K860272 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the Terminated |
FPA | K860272 |
| Jan 11, 2012 | Baxter Healthcare Corp. Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the Terminated |
FPA | K925126 |
| Jan 11, 2012 | ICU Medical, Inc. IV Start Kits
Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe. Terminated |
FPA | K033290 |
| Jan 11, 2012 | ICU Medical, Inc. Orbit and Orbit Micro
Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our d Terminated |
FPA | K033290 |
| Nov 25, 2011 | Hospira Inc. Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administ Terminated |
FPA | K101677 |
| Nov 17, 2011 | Medtronic Minimed Medtronic MiniMed paradigm mio Infusion Sets MMT-921
The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum. Terminated |
FPA | K051264 |
| Aug 3, 2011 | Baxter Healthcare Corp. Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL.
Baxter Healthcare Corporation.
A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvente Terminated |
FPA | K961225 |
| Jul 15, 2011 | Baxter Healthcare Corp. Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per cas Terminated |
FPA | K925126 |
| Jun 29, 2011 | Carefusion 303, Inc. MaxPlus bifuse extension set (minibore) needleless connectors,
Model Number: MP9232-C
Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vas Terminated |
FPA | K051499 |
| Jun 29, 2011 | Baxter Healthcare Corp. Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxt Terminated |
FPA | K925058 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Winged Infusion Set with 90 degree Huber Needle and Y Injection Site
Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683
Item # FIY-2210
Intended use: Intravascular Administratio Terminated |
FPA | K020544 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. FMI 105"Oral Surgery Administration Set;
Item AMS-468-1
Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems 14"Extension Set with SmartSite Injection
Item # 43000E
Intended use: Intravascular Administration Set Terminated |
FPA | K021395 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Fluid Transfer Set; Sterile
Item # AMS-451
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Manufactured for: WalkMed Infusion 96 Inverness Drive East, Suite 1 Englewood, CO 80112
Item # T100-000F
Int Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234
The Lifeguard Terminated |
FPA | K013871 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter
Item Number: AMS-944
Intended use: Intravascular Administration Terminated |
FPA | K021395 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical 78" Stopcock Extension Set with male/female red cap;
item # AMS-464-1
Intended use: Intravascular Administration Set Terminated |
FPA | K021395 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip
Manufactured for WalkMed Infusion 96 Inverness Drive East Suite 1 Engelwood, CO 80112
Item # Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Central Line Dressing Kit;
Item # AMS-8316CP-1
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set;
Manufactured for Walked Infusion 96 Inverness Drive East, Suite 14 Englewood, CO 80112
Item # T090-000
Intended use: Intravascular Administ Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site
Item # T090-000V
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Dec 1, 2010 | Baxter Healthcare Corp. Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product Terminated |
FPA | K970438 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter, Volume 1.0 mL, Length 6" (15 cm); an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FPA | K003225 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx ste Terminated |
FPA | K964918 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP Y-Type Catheter Extension Set, 6.6" (16.8 cm)., 1.1 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile devi Terminated |
FPA | K964918 |
| Oct 27, 2010 | Baxter Healthcare Corp. Baxter Non-DEHP I.V. Catheter Extension Set, 6.0" (15.2 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device; Terminated |
FPA | K964918 |
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