Set, Administration, Intravascular
FDA product code FPA · Class II (moderate risk) · 21 CFR 880.5440 · General Hospital
1,175510(k) clearances
0PMA approvals
941recalls
Manufacturers
- Baxter Healthcare Corp 67
- Abbott Laboratories 30
- Y 28
- ICU Medical, Inc. 27
- Sterling Medivations, Inc. 24
- B. Braun Medical, Inc. 22
- Travenol Laboratories, S.A. 21
- Churchill Corp. 15
- Hospira Inc. 14
- Nexus Medical, LLC 14
- Unomedical A/S 12
- Quest Medical, Inc. 12
- Medtronic Minimed 12
- Imed Corp. 12
- Marquette Medical, Inc. 11
- Douglas Medical Products Corp. 11
- Venospital, Inc. 11
- Kawasumi Laboratories Co., Ltd. 10
- Migada, Ltd. 10
- Medex, Inc. 9
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
| K250616 | Clave Neutral-Displacement Needlefree ConnectorsFPA · Traditional | Icu Medical, Inc. | 06/05/2025SE |
| K242692 | SteadiSet Infusion SetFPA · Abbreviated | Capillary Biomedical, LLC | 05/09/2025SE |
| K242763 | JetCan® Pro Safety Huber NeedleFPA · Traditional | Pfm Medical, Inc. | 05/02/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | Baxter Healthcare Corporation | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | Baxter Healthcare Corporation | 02/28/2025SE |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y)FPA · Traditional | Quest Medical, Inc. | 12/18/2024SE |
| K234129 | Ecomed Disposable Administration SetsFPA · Traditional | Ecomed Solutions, LLC | 09/20/2024SE |
| K242126 | I.V. Administration SetFPA · Special | Bq Plus Medical Co., Ltd. | 08/22/2024SE |
| K232475 | Disposable infusion set with needleFPA · Traditional | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 05/10/2024SE |
| K222766 | Disposable Extension SetFPA · Traditional | Shandong Ande Healthcare Apparatus Co., Ltd. | 04/12/2024SE |
| K232328 | Insignis Syringe Infusion SystemFPA · Traditional | Innovative Health Sciences, LLC | 03/01/2024SE |
| K231707 | ResQ Administration SetFPA · Traditional | Q For Plastic Industries | 01/03/2024SE |
| K230528 | Extension SetFPA · Traditional | Medcaptain Life Science Co., Ltd. | 12/01/2023SE |
| K222780 | LILY Extension Tube and Needleless ConnectorFPA · Traditional | Lily Medical Corporation | 11/09/2023SE |
| K230343 | ProSeal Closed System Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 11/03/2023SE |
| K221327 | BD Alaris Pump Infusion SetsFPA · Traditional | Care Fusion | 07/21/2023SE |
| K221411 | Surflo Winged Infusion SetFPA · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 06/23/2023SE |
| K221121 | Volumat Polyethylene I.V. Administration SetFPA · Traditional | Fresenius Kabi | 06/16/2023SE |
| K230992 | DJF Intravascular Administration SetFPA · Traditional | Yangzhou Wei DE LI Trade Co., Ltd. | 06/09/2023SE |
| K220301 | Volumat LineFPA · Traditional | Fresenius Kabi | 06/02/2023SE |
| K223645 | I.V. Administration Set, I.V. Extension SetFPA · Traditional | Bq Plus Medical Co., Ltd. | 05/18/2023SE |
| K223101 | BD Secondary Infusion SetFPA · Traditional | Care Fusion | 05/12/2023SE |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral…FPA · Traditional | Np Medical, Inc. | 04/19/2023SE |
| K220312 | Polyfusion IV Administration SetsFPA · Traditional | Poly Medicure Limited | 04/12/2023SE |
| K223088 | BD SmartSite Needle-Free ConnectorFPA · Traditional | Care Fusion | 04/07/2023SE |
| K222889 | FlowArt® Needle-Free Split Septum ValveFPA · Traditional | Asset Medikal Tasarim San Tic As. | 01/20/2023SE |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseFPA · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 11/21/2022SE |
| K221075 | Infusion Sets for Single UseFPA · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 11/21/2022SE |
| K221069 | Infusion Sets for Single Use with NeedlesFPA · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 11/21/2022SE |
| K221518 | NP Medical nCompass Extension Set with Stabilizing BaseFPA · Traditional | Np Medical | 11/03/2022SE |
| K220267 | AMSafe NeuFlo Needleless ConnectorFPA · Traditional | Amsino International, Inc. | 10/07/2022SE |
| K212262 | PCA Syringe SetsFPA · Traditional | Baxter Healthcare Corporation | 10/03/2022SE |
| K221473 | FlowartFPA · Traditional | Asset Medikal Tasarim As. | 09/26/2022SE |
| K221481 | NeutrArtFPA · Traditional | Asset Medikal Tasarim As. | 09/23/2022SE |
| K213846 | Q2 Blood Administration SetsFPA · Traditional | Quest Medical, Inc. | 06/05/2022SE |
| K213588 | Q2 IV Administration SetsFPA · Traditional | Quest Medical, Inc. | 06/02/2022SE |
| K213004 | Needle Free ConnectorFPA · Traditional | Medcaptain Life Science Co., Ltd. | 05/10/2022SE |
| K202437 | Infusion Sets for Single UseFPA · Traditional | Jiangsu Suyun Medical Materials Co., Ltd. | 03/25/2022SE |
| K213778 | IV Administration SetFPA · Traditional | B.Braun Medical, Inc. | 03/03/2022SE |
| K212842 | Microvolume Luer Access DeviceFPA · Traditional | B.Braun Medical, Inc. | 01/18/2022SE |
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPA · Special | Ivenix, Inc. | 11/10/2021SE |
| K203609 | Intravascular Administration SetsFPA · Traditional | Baxter Healthcare Corporation | 09/30/2021SE |
| K202618 | IV Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 09/24/2021SE |
| K210381 | I.V. Administration SetFPA · Traditional | Bq Plus Medical Co., Ltd. | 08/14/2021SE |
| K202279 | Insignis Subcutaneous Needle SetsFPA · Traditional | Innovative Health Sciences, LLC | 08/13/2021SE |
| K203796 | Firefly Needleless ConnectorFPA · Traditional | Puracath Medical, Inc. | 07/30/2021SE |
| K210544 | Medtronic Extended infusion setFPA · Traditional | Unomedical A/S | 07/16/2021SE |
| K210430 | Intravascular Extension SetFPA · Traditional | Baxter Healthcare Corporation | 06/18/2021SE |
| K210217 | Needleless ConnectorFPA · Traditional | Jiangsu Caina Medical Co.,Ltd | 05/17/2021SE |
| K201626 | Safety Subcutaneous Infusion SetFPA · Traditional | Epic Medical Pte. , Ltd. | 03/24/2021SE |
| K200439 | Velano ExT Extension SetFPA · Traditional | Velano Vascular | 02/23/2021SE |
| K202672 | Precision Delivery Infusion SetFPA · Traditional | Quest Medical, Inc. | 01/21/2021SE |
| K201872 | NeutrArtFPA · Traditional | Asset Medikal Tasarim As. | 01/05/2021SE |
| K200425 | Female Luer Lock CapFPA · Traditional | Medsafety Solutions, LLC | 10/29/2020SE |
| K193088 | MaxZero Extension Sets with Needle-Free Connector(s)FPA · Traditional | Carefusion, Inc. | 10/23/2020SE |
| K200661 | Steripath Micro Blood Collection SystemFPA · Special | Magnolia Medical Technologies, Inc. | 10/08/2020SE |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration SetsFPA · Traditional | Smiths Medical Asd, Inc. | 09/18/2020SE |
| K191640 | TK Intravascular Administration SetFPA · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/26/2020SE |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…FPA · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 07/28/2020SE |
| K192366 | Intravascular Extension Sets and AccessoriesFPA · Traditional | Baxter Healthcare Corporation | 07/20/2020SE |
| K191362 | LifeFlow Blood SystemFPA · Traditional | 410 Medical, Inc. | 05/20/2020SE |
| K191658 | IV Sets not made with PVCFPA · Traditional | B.Braun Medical, Inc. | 03/19/2020SE |
| K190806 | FlowartFPA · Traditional | Asset Medikal Tasarim As. | 02/20/2020SE |
| K192647 | neria guard Infusion SetFPA · Traditional | Unomedical A/S | 12/13/2019SE |
| K180739 | Clearlink System Solution SetFPA · Traditional | Baxter Healthcare Corporation | 05/28/2019SE |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS)FPA · Special | Kawasumi Laboratories, Inc. | 05/02/2019SE |
| K180843 | HIgH-Flo Super26 Subcutaneous Needle SetsFPA · Traditional | Repro-Med Systems, Inc. Dba Rms Medical Products | 04/04/2019SE |
| K182897 | Velano Vascular Q2 Extension SetFPA · Traditional | Velano Vascular | 03/26/2019SE |
| K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single…FPA · Traditional | Wuhan W.E.O Science & Technology Development… | 02/26/2019SE |
| K182545 | Tamper Evident Cap with Male Luer LockFPA · Traditional | International Medical Industries, Inc. | 01/11/2019SE |
| K181718 | BD FlowSmart Set/MiniMed Pro-SetFPA · Traditional | Becton, Dickinson and Company | 10/18/2018SE |
| K173665 | AMSafe Sure-Lok Needle-Free ConnectorFPA · Traditional | Amsino International, Inc. | 09/05/2018SE |
| K173361 | IV Administration SetFPA · Traditional | B.Braun Medical, Inc. | 06/26/2018SE |
| K173879 | MiniMed Mio Advance infusion setFPA · Traditional | Unomedical A/S | 03/05/2018SE |
| K170595 | IV Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 11/07/2017SE |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…FPA · Traditional | Unomedical A/S | 11/01/2017SE |
| K172544 | IV Fat Emulsion Administration SetsFPA · Special | Baxter Healthcare Corporation | 09/22/2017SE |
| K170002 | Medline Blood Collection SetFPA · Traditional | Medline Industries, Inc. | 09/19/2017SE |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000)FPA · Traditional | Cair Lgl | 09/01/2017SE |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)FPA · Traditional | Cair Lgl | 08/15/2017SE |
| K171132 | Carefusion NeutraClear Needle-free connectorFPA · Special | Cair Lgl | 07/31/2017SE |
| K162951 | TUBETECH IV Administration SetFPA · Traditional | Douglas Medical Products, Inc. | 07/28/2017SE |
| K171957 | MaxZero Extension Sets with Needless ConnectorFPA · Traditional | Carefusion 303, Inc. | 07/19/2017SE |
| K161808 | Solution Set with 1.2 Micron Air Eliminating FilterFPA · Traditional | Baxter Healthcare Corporation | 06/21/2017SE |
| K162826 | Encore NeutralFPA · Traditional | Rymed Technologies, LLC | 06/15/2017SE |
| K171101 | Closed Male LuerFPA · Traditional | Yukon Medical | 06/02/2017SE |
| K162601 | Infusion Set for Single UseFPA · Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. | 05/31/2017SE |
| K163160 | Sterile Single-use Infusion SetFPA · Traditional | Jiangxi Hongda Medical Equipment Group , Ltd. | 04/20/2017SE |
| K162804 | Q2 Low Pressure Power Injection Extension SetFPA · Traditional | Quest Medical, Inc. | 03/08/2017SE |
| K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision…FPA · Traditional | Beijing Fert Technology Co., Ltd. | 03/08/2017SE |
| K161036 | Hospira Extension Set, Hospira Primary SetFPA · Traditional | Hospira, Inc. | 01/06/2017SE |
| K160007 | Paclitaxel SetsFPA · Traditional | Baxter Healthcare Corporation | 12/19/2016SE |
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…FPA · Traditional | Quest Medical, Inc. | 12/06/2016SE |
| K161323 | Solution Set for Epidural UseFPA · Traditional | Baxter Healthcare Corporation | 11/30/2016SE |
| K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device)FPA · Traditional | 410 Medical Innovation, LLC | 08/25/2016SE |
| K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetFPA · Traditional | C.R. Bard, Inc. | 08/18/2016SE |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA · Traditional | Unomedical A/S | 08/10/2016SE |
| K151250 | Smart SetFPA · Abbreviated | Top Spins, Inc. | 06/07/2016SE |
| K160870 | Hospira Administration SetsFPA · Special | Hospira, Inc. | 06/01/2016SE |
| K150921 | Orbit Infusion SetFPA · Traditional | Ypsomed AG | 04/12/2016SE |
| K160651 | BD FlowSmart Set, MiniMed Pro-SetFPA · Special | Becton, Dickinson and Company | 04/07/2016SE |
| K153293 | Extension SetFPA · Traditional | B.Braun Medical, Inc. | 04/06/2016SE |
| K151969 | Hospira Extension SetsFPA · Traditional | Icu Medical, Inc. | 01/19/2016SE |
| K153158 | Solution Administration Sets with 0.2 Micron FilterFPA · Special | Baxter Healthcare Corporation | 12/28/2015SE |
| K153257 | BD FlowSmart Set, MiniMed Pro-SetFPA · Special | Becton, Dickinson and Company | 12/11/2015SE |
| K151079 | Q2 Intravenous Adminstration Sets and Extension SetsFPA · Traditional | Quest Medical, Inc. | 09/30/2015SE |
| K151151 | U & U Intravascular Administration SetFPA · Traditional | U&U Medical Technology Co, Ltd. | 09/24/2015SE |
| K143446 | Accu-Chek FlexLink Plus infusion setFPA · Traditional | Roche Diagnostics GmbH | 08/13/2015SE |
| K143082 | IV Administration Sets with 200(micro)m Blood FilterFPA · Traditional | B.Braun Medical, Inc. | 07/24/2015SE |
| K150513 | Imed Technology Intravascular Administration Set, Imed Technology Extension SetFPA · Abbreviated | Imed Technology, Inc. | 05/28/2015SE |
| K150059 | BD FlowSmart SetFPA · Traditional | Becton, Dickinson Company | 04/28/2015SE |
| K150860 | Nitroglycerin Sets with DUO-VENT SpikeFPA · Traditional | Baxter Healthcare Corporation | 04/16/2015SE |
| K143087 | Hospira Blood SetFPA · Traditional | Hospira, Inc. | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | Hospira, Inc. | 02/25/2015SE |
| K141285 | Busse Extension SetFPA · Traditional | Busse Hospital Disposables | 02/19/2015SE |
| K142590 | All Safe Huber Safety Infusion SetFPA · Traditional | Nexus Medical, LLC | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | Hospira, Inc. | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | Hospira, Inc. | 01/09/2015SE |
| K142433 | Hospira Extension SetFPA · Traditional | Hospira, Inc. | 12/08/2014SE |
| K140838 | IV Administration Set with Hand PumpFPA · Traditional | B.Braun Medical, Inc. | 12/05/2014SE |
| K142367 | Hospira Primary SetsFPA · Traditional | Hospira, Inc. | 11/25/2014SE |
| K143234 | MaxZero Administration SetsFPA · Traditional | Care Fusion | 11/20/2014SE |
| K141200 | Padi-LockFPA · Traditional | Padi-Lock, LLC | 10/02/2014SE |
| K142527 | Extension Set with BD Q-Syte Luer Access Split SeptumFPA · Traditional | Acacia, Inc. | 09/19/2014SE |
| K142097 | SELEC-3 I.V.Administration SetFPA · Special | Biomedix, Inc. | 08/29/2014SE |
| K142036 | Infusomat Space Volumetric Infusion Pump Administration SetsFPA · Special | B.Braun Medical, Inc. | 08/25/2014SE |
| K142011 | Solution Set/Extension SetFPA · Special | Baxter Healthcare Corporation | 08/18/2014SE |
| K141834 | Sapphire Administration SetFPA · Special | Q Core Medical , Ltd. | 08/05/2014SE |
| K140175 | Intravascular Administration SetFPA · Traditional | Delta Med Spa | 08/05/2014SE |
| K141306 | Tevadaptor; Connecting Set W/ Ultrasite Injection Site, Spike Port Adaptor Set W/…FPA · Special | Teva Medical Ltd., Migada Plant | 06/12/2014SE |
| K133351 | Nexus NIS-6P Luer Activated DeviceFPA · Traditional | Nexus Medical, LLC | 05/22/2014SE |
| K140133 | Infuset Flow Control Extension SetFPA · Traditional | Emed Technologies Corporation | 05/15/2014SE |
| K140311 | Caresite Luer Access DeviceFPA · Traditional | B.Braun Medical, Inc. | 05/07/2014SE |
| K140831 | Maxzero Extension Set with Needless ConnectorFPA · Traditional | Care Fusion | 04/15/2014SE |
| K140131 | Sub-Q Subcutaneous Tissue Infusion SetFPA · Special | Emed Technologies Corporation | 04/03/2014SE |
| K133073 | Cair Drive, NeutraclearFPA · Traditional | Cair Lgl | 03/20/2014SE |
| K133894 | Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)FPA · Traditional | Terumo Europe N.V. | 03/18/2014SE |
| K133867 | Surflo Winged Infusion Set with Needle Protection (Surshield)FPA · Special | Terumo Europe N.V. | 02/05/2014SE |
| K132841 | Zyno Medical Administration SetFPA · Special | Zyno Medical, LLC | 01/23/2014SE |
| K132880 | Medcomp Power Injectable Safety Huber NeedleFPA · Traditional | Medical Components, Inc. | 01/08/2014SE |
| K132734 | Neutral Luer Activated Device (One-Link Needle-Free IV Connector) and Extension SetsFPA · Special | Baxter Healthcare Corp | 10/08/2013SE |
| K132142 | Neria Soft 90 Infusion SetFPA · Traditional | Unomedical A/S | 10/08/2013SE |
| K132413 | MZ1000FPA · Traditional | Care Fusion | 08/29/2013SE |
| K130879 | Nexus IV Tubing Set with Luer-Accessbile One-Way Check Valve - IV PlusFPA · Traditional | Nexus Medical, LLC | 07/09/2013SE |
| K130416 | Nexus TKO-6P Luer Activated DeviceFPA · Traditional | Nexus Medical, LLC | 06/12/2013SE |
| K122404 | Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614…FPA · Traditional | Repro-Med Systems, Inc. Dba Rms Medical Products | 05/06/2013SE |
| K130023 | K100 Neutral Displacement Needle Free ConnectorFPA · Traditional | Np Medical, Inc. | 04/03/2013SE |
| K130468 | Orbit Infusion SetFPA · Special | Ypsomed AG | 03/19/2013SE |
| K123344 | K-Shield Advantage Port Access Infusion Set (Pais)FPA · Traditional | Kawasumi Laboratories, Inc. | 03/07/2013SE |
| K121511 | Maclin Power Intravascular Administration SetFPA · Traditional | Maclin Power, Inc. | 03/07/2013SE |
| K121269 | TbaFPA · Traditional | Migada Plant | 01/22/2013SE |
| K123874 | Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets…FPA · Special | Baxter Healthcare Corp | 01/10/2013SE |
| K123868 | Interlink System Lever Lock Cannula with Check Valve, Secondary Medication Sets…FPA · Special | Baxter Healthcare Corp | 01/08/2013SE |
| K123729 | Versarate Flow Rate ControlerFPA · Traditional | Emed Technologies Corporation | 12/21/2012SE |
| K121803 | Intravascular Administration SetFPA · Abbreviated | Acta Medical, LLC | 12/19/2012SE |
| K122686 | Accu-Chek Ultraflex Infusion SetFPA · Special | Roche Diabetes Care AG | 11/16/2012SE |
| K113471 | Nipro Huber Infusion Set, Excel Huber Infusion SetFPA · Traditional | Nipro Medical Corporation | 10/18/2012SE |
| K113470 | Nipro Safe Touch Huber Infusion SetFPA · Traditional | Nipro Medical Corporation | 10/17/2012SE |
| K120685 | Zyno Medical Administration SetFPA · Abbreviated | Zyno Medical, LLC | 09/07/2012SE |
| K120195 | Safety Subcutaneous Tissue Infusion SetFPA · Traditional | Multi Med | 07/06/2012SE |
| K121634 | Interlink System Extension Set with Control-A-Flo-Regulatory Clearlink System Extension…FPA · Special | Baxter Healthcare Corporation | 06/29/2012SE |
| K121092 | Flowease [Subcutaneous] Infusion SetFPA · Traditional | Baxter Healthcare Corp | 06/29/2012SE |
| K120375 | Med-Rx Patient Delivery SetFPA · Traditional | Benlan, Inc. | 06/28/2012SE |
| K121032 | Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-DehpFPA · Special | Hospira, Inc. | 06/21/2012SE |
| K121554 | Q-Flo Closed Male Luer ConnectorFPA · Traditional | Us Fusion, LLC. Dba Truecare Biomedix-USA | 06/08/2012SE |
| K120395 | Neria Multi Subcutaneous Infusion SetFPA · Traditional | Unomedical Devices S.A DE C.V. | 05/30/2012SE |
| K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceFPA · Traditional | Baxter Healthcare Corporation - Renal Division | 05/22/2012SE |
| K120548 | Hlic Needle-Less ValveFPA · Traditional | Health Line International Corporation | 05/04/2012SE |
| K120261 | PPS Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS Pi…FPA · Traditional | Perouse Medical | 05/02/2012SE |
| K120872 | Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl…FPA · Special | Unomedical A/S Infusion Devices | 04/20/2012SE |
| K113398 | Nexus TKO-6, Luer-Activated DeviceFPA · Traditional | Nexus Medical, LLC | 04/18/2012SE |
| K112073 | Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless…FPA · Traditional | Rx Devices, LLC | 04/11/2012SE |
| K120799 | Arisure Neutral ValveFPA · Traditional | Yukon Medical, LLC | 03/30/2012SE |
| K113683 | Lifeshield Vision Infusion Set with Pre-Pierced ResealFPA · Special | Hospira, Inc. | 01/12/2012SE |
| K112799 | Med-Rx Extension Set with T-ConnectorFPA · Traditional | Benlan, Inc. | 12/23/2011SE |
| K112636 | Cytoguard(Tm) Closed Luer ConnectorFPA · Traditional | B.Braun Medical, Inc. | 11/26/2011SE |
| K112512 | Vanishpoint Blood Collection SetFPA · Traditional | Retractable Technologies, Inc. | 10/20/2011SE |
| K112893 | Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsFPA · Special | Baxter Healthcare Corporation | 10/18/2011SE |
| K111351 | Truecare Biomedix Intravascular Administration Set, Truecare Biomedix Extension SetFPA · Abbreviated | Us Infusion Dba Truecare Biomedix | 09/29/2011SE |
| K102405 | Infusion Set for Powerpicc Solo 2 CatheterFPA · Traditional | C.R. Bard, Inc. | 07/21/2011SE |
| K103562 | Centurion Pressure Injectable Extension SetFPA · Abbreviated | Centurion Medical Products Corporation | 06/23/2011SE |
| K111016 | Safeport Manifold (TM) (or Stopcock)FPA · Special | Elcam Medical Acal | 06/09/2011SE |
| K102512 | RMS Subcutaneous Needle SetFPA · Traditional | Repro-Med Systems, Inc. | 05/20/2011SE |
| K110282 | Lighty DD Infusion SetFPA · Traditional | Medx-Set, Ltd. | 04/27/2011SE |
| K103551 | Interlink S / Clearlink System / V-Link Lad with Vitalshield Protective Coating Non-Dehp…FPA · Traditional | Baxter Healthcare Corp | 03/25/2011SE |
| K103224 | Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingFPA · Special | Hospira, Inc. | 01/07/2011SE |
| K100576 | High Pressure SETS-400 PsiFPA · Traditional | Icu Medical, Inc. | 12/17/2010SE |
| K103344 | Infusion SetsFPA · Special | Hospira, Inc. | 12/10/2010SE |
| K101368 | D. Heart Medical Intravascular Administration Set, Safety Acces Device and AccessoriesFPA · Abbreviated | Dragon Heart Medical, Inc. | 11/18/2010SE |
| K100720 | K-Shield Port Access Infusion Set with High Pressure TubingFPA · Traditional | Kawasumi Laboratories, Inc. | 11/18/2010SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3080-2026 | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to… | BD Switzerland Sarl | 08/19/2026Open, Classified |
| Z-3089-2026 Class II | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number:…Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton… | B Braun Medical Inc | 08/04/2026Open, Classified |
| Z-2766-2026 Class I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in… | Baxter Healthcare Corporation | 06/30/2026Open, Classified |
| Z-2941-2026 Class II | 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext…Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product… | BD Switzerland Sarl | 06/16/2026Open, Classified |
| Z-2645-2026 Class II | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog…May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus… | Medela Inc | 06/05/2026Open, Classified |
| Z-2654-2026 Class II | MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461…Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. | BD Switzerland Sarl | 06/04/2026Open, Classified |
| Z-3160-2026 | IV Sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | ICU Medical, Inc. | 05/12/2026Open, Classified |
| Z-3158-2026 | Oncology sets with drip chambersIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | ICU Medical, Inc. | 05/12/2026Open, Classified |
| Z-3156-2026 | Plum administration setsIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic… | ICU Medical, Inc. | 05/12/2026Open, Classified |
| Z-1774-2026 Class II | See Luer Cap Set, MPC-130, set, administration, intravascularMolded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set… | Molded Products Inc | 02/17/2026Open, Classified |
| Z-1366-2026 Class II | Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN…Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer… | Medline Industries, LP | 12/31/2025Open, Classified |
| Z-1111-2026 Class II | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to… | ICU Medical, Inc. | 12/19/2025Open, Classified |
| Z-0718-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0716-2026 Class II | Outlook set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0715-2026 Class II | Vista set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0714-2026 Class II | ULTRASITE set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0713-2026 Class II | SAFELINE set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0712-2026 Class II | SafeDAY set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0711-2026 Class II | SafeDAY set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0710-2026 Class II | RATE FLOW set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0709-2026 Class II | Outlook set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0707-2026 Class II | Outlook set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0706-2026 Class II | Outlook set utilized in gravity IV administration sets and pump administration sets…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0705-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0704-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0703-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0702-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0701-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0700-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0699-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0698-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0697-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0696-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0695-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0694-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0693-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0692-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0691-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0690-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0689-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0688-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0687-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0686-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0685-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0684-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0683-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0682-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0678-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0677-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |
| Z-0676-2026 Class II | IV Administration Set utilized in gravity IV administration sets and pump administration…Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and… | B Braun Medical Inc | 10/29/2025Open, Classified |