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) |
|---|---|---|---|
| Jan 9, 2014 | ICU Medical, Inc. 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3
Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029
The ICU Needleless Connector is a single use, sterile, non-pyrogenic devic Terminated |
FPA | K970855 |
| Jan 9, 2014 | ICU Medical, Inc. 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector,
Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device Terminated |
FPA | K970855 |
| Jan 9, 2014 | ICU Medical, Inc. NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessor Terminated |
FPA | K970855 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4)
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convatec;
Lejre Terminated |
FPA | K120872 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4)
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convate Terminated |
FPA | K120872 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4);
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convatec Terminated |
FPA | K120872 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4)
Distributed by Asante Solutions,
Sunnyvale, CA;
Manufactured by Convatec; Terminated |
FPA | None listed |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4).
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by Terminated |
FPA | K120872 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4).
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by:
U Terminated |
FPA | K120872 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4).
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by:
Un Terminated |
FPA | K120872 |
| Dec 27, 2013 | Asante Solutions, Inc. Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4)
Manufactured for:
Asante Solutions
Sunnyvale, CA;
Manufactured by:
Uno Terminated |
FPA | K120872 |
| Dec 4, 2013 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T
The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications throug Terminated |
FPA | K944320 |
| Dec 3, 2013 | CareFusion 303, Inc. VersaSafe Extension Set, Model No. 21000M-007 Terminated |
FPA | K944320 |
| Oct 30, 2013 | Baxter Healthcare Corp. Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA.
An IV transfer devic Terminated |
FPA | None listed |
| Oct 29, 2013 | Baxter Healthcare Corp. Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. Terminated |
FPA | K112893 |
| Sep 26, 2013 | CareFusion 303, Inc. CareFusion Gravity Set, Model #44000-07
The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Terminated |
FPA | K820278 |
| Sep 26, 2013 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. Terminated |
FPA | K944320 |
| Sep 26, 2013 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set, Model#72313E
The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery o Terminated |
FPA | K931550 |
| Sep 18, 2013 | Churchill Medical Systems, Inc. Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Appli Terminated |
FPA | K963981 |
| Sep 18, 2013 | Churchill Medical Systems, Inc. Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. Terminated |
FPA | K963981 |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 I Terminated |
FPA | K982159 |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: Terminated |
FPA | K052052 |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage:
The CLAVE of the secondary port i Terminated |
FPA | K101677 |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 M Terminated |
FPA | K982159 |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; Terminated |
FPA | K103224 |
| Jul 18, 2013 | Hospira Inc. LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the ad Terminated |
FPA | None listed |
| Jul 9, 2013 | Medtronic MiniMed Medtronic MiniMed Paradigm Insulin Infusion Sets
The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. Terminated |
FPA | K011071 |
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only
Product Usage:
The IV extension tubing kits ar Terminated |
FPA | K112893 |
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabiliza Terminated |
FPA | K103551 |
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only
Product Usage:
This device is indicated for use in bl Terminated |
FPA | K925126 |
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only;
B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. Terminated |
FPA | K811078 |
| Mar 6, 2013 | Churchill Medical Systems, Inc. Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010
Huber type needle set used for the infusion of medical fluids into implantable ports. Terminated |
FPA | K013871 |
| Feb 15, 2013 | Carefusion 303 Inc CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein. Terminated |
FPA | K882302 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Side Step Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary VSA Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infus Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary Spike Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide inf Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary Spike Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infus Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary VSA Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusio Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provid Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Primary Set
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion th Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Secondary Administration Kit
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to pr Terminated |
FPA | K051499 |
| Dec 20, 2012 | Medrad Inc Medrad(R) Continuum MR Infusion System Standard Administration Kit
Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to pro Terminated |
FPA | K051499 |
| Dec 14, 2012 | Baxter Healthcare Corp. Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case;
For the administration of drugs Terminated |
FPA | K042936 |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device
Product Usage: The device is used Terminated |
FPA | K984381 |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the a Terminated |
FPA | K984381 |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device;
Product Usage: The device is used for t Terminated |
FPA | K984381 |
| Oct 9, 2012 | Baxter Healthcare Corp. Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the administration of fluids Terminated |
FPA | K984381 |
| Aug 9, 2012 | Medical Specialties Distributors, Inc. Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile
Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China
Product Numb Terminated |
FPA | K090012 |
| Jul 25, 2012 | Hospira Inc. Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx Terminated |
FPA | K101677 |
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