Transducer, Blood-Pressure, Extravascular
FDA product code DRS · Class II (moderate risk) · 21 CFR 870.2850 · Cardiovascular
149510(k) clearances
0PMA approvals
236recalls
Manufacturers
- Medex, Inc. 7
- Sorensen Research 7
- Gould, Inc. 6
- Transamerica Delaval, Inc. 6
- Hewlett-Packard Co. 5
- Bentley Laboratories, Inc. 4
- Norton Performance Plastics Corp. 4
- Graphic Controls Corp. 4
- Mirador Biomedical, Inc. 4
- Bio-Med Corp. 4
- Utah Medical Products, Inc. 3
- American Bentley 3
- Sunscope Intl., Inc. 3
- Edwards Lifesciences, LLC 3
- Narco Scientific 3
- American Pharmaseal Div. Ahsc 3
- North American Instrument Corp. 3
- Linton Biomed Corp. 3
- Namic 2
- Gics Pharmaceuticals 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254074 | TruPressDRS · Traditional | Procerus Enterprises | 09/10/2026SE |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS · Special | Edwards Lifesciences, LLC | 03/21/2025SE |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesDRS · Traditional | Merit Medical Pte. , Ltd. | 03/17/2023SE |
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 11/09/2017SE |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 05/24/2017SE |
| K161408 | Compass Cast and MAPDRS · Traditional | Centurion Medical Products Corporation | 11/22/2016SE |
| K152472 | Disposable Pressure TransducerDRS · Traditional | Zhejiang Haisheng Medical Device Co., Ltd. | 10/31/2016SE |
| K152980 | Flo Trac sensor, Volume View sensorDRS · Traditional | Edwards Lifesciences, LLC | 01/19/2016SE |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure…DRS · Traditional | Biometrix , Ltd. | 09/04/2015SE |
| K133624 | Compass CT, Compass CT PortDRS · Traditional | Mirador Biomedical | 04/18/2014SE |
| K123095 | Medline Blood Pressure TransducerDRS · Abbreviated | Medline Industries, Inc. | 05/08/2013SE |
| K120624 | Elcam Disposable Integrated Pressure Transducer (Dipt)DRS · Traditional | Elcam Medical Acal | 06/08/2012SE |
| K112203 | Compass Global Pressure, Compass Thoracentesis, Paracentesis, Compartment Pressure…DRS · Traditional | Mirador Biomedical, Inc. | 12/14/2011SE |
| K102033 | Combitrans Monitoring Sets and AccessoriesDRS · Abbreviated | B.Braun Melsungen AG | 04/07/2011SE |
| K103715 | Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial PressureDRS · Special | Mirador Biomedical, Inc. | 01/20/2011SE |
| K101189 | Reavillmed Pressure Monitoring System and PiccDRS · Traditional | Reavillmed | 12/22/2010SE |
| K101518 | Compass Vascular Access; Compass Lumbar PunctureDRS · Traditional | Mirador Biomedical, Inc. | 10/13/2010SE |
| K092644 | Terumo Pressure IsolatorDRS · Traditional | Terumo Cardiovascular Systems Corp. | 12/10/2009SE |
| K091408 | Disposable Pressure TransducerDRS · Traditional | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 08/18/2009SE |
| K070710 | Accutrans Disposable Pressure Monitoring SystemDRS · Special | Biosensors International-USA | 04/19/2007SE |
| K062342 | Truepulse Disposable Invasive Blood Pressure Monitoring KitDRS · Traditional | Sentra Medical Devices, LLC | 09/25/2006SE |
| K061573 | Transpac III Disposable Straight Pressure Transducer and KitDRS · Special | Hospira, Inc. | 09/19/2006SE |
| K052828 | Disposable Transpac III Integrated Transducer (It)DRS · Special | Hospira, Inc. | 02/17/2006SE |
| K043065 | Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models MIHM1 and MIHM1PDRS · Traditional | Edwards Lifesciences, LLC | 01/26/2005SE |
| K983372 | Bioport Closed Blood Sampling System, Model BT Xxxxxx- BPDRS · Traditional | Sunscope Intl., Inc. | 02/05/1999SE |
| K981747 | Biotrans Pressure Monitoring Kit Model Number BT XxxxxxDRS · Traditional | Sunscope Intl., Inc. | 08/20/1998SE |
| K981745 | Biotrans Reusable Sensor Base Model Number BT XxxxxxDRS · Traditional | Sunscope Intl., Inc. | 07/17/1998SE |
| K961404 | MX960 Reusable Pressure TransducerDRS · Traditional | Medex, Inc. | 06/27/1996SE |
| K951722 | Perceptor Compensator Morse ManifoldDRS · Traditional | Namic | 03/25/1996SE |
| K951129 | Novatrans IIDRS · Traditional | Medex, Inc. | 04/05/1995SE |
| K930888 | Wristrecorder Plus Cardiac Event Recording SystemDRS · Traditional | Ralin Medical, Inc. | 07/21/1993SE |
| K921343 | Cobe Patient Monitoring ProductsDRS · Traditional | Cobe Cardiovascular, Inc. | 01/05/1993SE |
| K920977 | Meritrans(Tm) Disposable TransducerDRS · Traditional | Merit Medical Systems, Inc. | 12/11/1992SE |
| K921898 | Tad Model #9655DRS · Traditional | Loric Technology | 11/02/1992SE |
| K910764 | The Perceptor(Tm) Stand Alone TransducerDRS · Traditional | North American Instrument Corp. | 04/22/1991SE |
| K904777 | Series 51 and 53 Disposable Pressure TransducersDRS · Traditional | Baxter Healthcare Corp | 01/15/1991SE |
| K904601 | Advance Disposable Pressure TransducerDRS · Traditional | Advance Medical Designs, Inc. | 12/17/1990SE |
| K902472 | Morse DT ManifoldDRS · Traditional | North American Instrument Corp. | 08/23/1990SE |
| K902453 | Oscillometric Pulse Detection DeviceDRS · Traditional | Thomas J. Fogarty, M.D. | 08/23/1990SE |
| K900551 | Matrx Disposable Non-Invasive Gelled Pacing Elec.DRS · Traditional | Matrix Medica, Inc. | 05/09/1990SE |
| K884235 | Combitrans Disposable Pressure Transducer KitDRS · Traditional | Burron Medical, Inc. | 03/06/1990SE |
| K885296 | Miniflow Disposable Pressure Transducer 63-600FDRS · Traditional | Baxter Healthcare Corp | 01/25/1989SE |
| K884919 | Disposable Dome Stock #D-300DRS · Traditional | Advanced Medical, Inc. | 01/05/1989SE |
| K881297 | Baro-Graf 24DRS · Traditional | Instromedix, Inc. | 09/16/1988SE |
| K883095 | MX860, Reusable Pressure TransducerDRS · Traditional | Medex, Inc. | 09/12/1988SE |
| K882118 | Model 700 Patient MonitorDRS · Traditional | Ivy Biomedical Systems, Inc. | 08/02/1988SE |
| K873168 | Spectramed Disposable Transducer (Dt-Xxo) & AccessDRS · Traditional | Spectramed, Inc. | 01/12/1988SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | American Edwards Laboratories | 09/30/1987SE |
| K871371 | Digital SphygmomanometerDRS · Traditional | Omron Tateisi Electronics Co. | 06/12/1987SE |
| K870356 | Tatch-ItDRS · Traditional | Reunion Medical Co. | 06/12/1987SE |
| K870301 | MX900-DPT, Disposable Pressure TransducerDRS · Traditional | Medex, Inc. | 05/06/1987SE |
| K864090 | Shelf Life Change of Sterile DevicesDRS · Traditional | Utah Medical Products, Inc. | 03/20/1987SE |
| K862344 | Gould XcaliberDRS · Traditional | Bio-Tek Instruments, Inc. | 08/06/1986SE |
| K860681 | Disposable Flush DeviceDRS · Traditional | Hewlett-Packard Co. | 06/17/1986SE |
| K854596 | TDK ECG Electrode MEL-08-09 & -11DRS · Traditional | Tdk Corp. | 05/07/1986SE |
| K853996 | Disposable Pressure Transducer System SterileDRS · Traditional | Transamerica Delaval, Inc. | 05/07/1986SE |
| K855145 | Model:Ta-Rose Resonant Overshoot EliminatorDRS · Traditional | Gould, Inc. | 02/26/1986SE |
| K854505 | Cardimax FX-406UDRS · Traditional | Brentwood Instruments, Inc. | 02/04/1986SE |
| K852652 | Omnigraph 4000(ELECTROCARDIOGRAPH)DRS · Traditional | Telemed Div. | 11/19/1985SE |
| K841960 | Cardio Metrics Invasive Pressure MonitDRS · Traditional | Sterile Design, Inc. | 11/08/1985SE |
| K851486 | Gould Disposable Transducer & Accessories-DtxDRS · Traditional | Gould, Inc. | 10/17/1985SE |
| K841811 | Bentley-Trantec Dispos. Domes D-260-DRS · Traditional | American Bentley | 09/09/1985SE |
| K851989 | Dome, Disposable, SterileDRS · Traditional | Transamerica Delaval, Inc. | 08/19/1985SE |
| K851988 | Administration SetDRS · Traditional | Transamerica Delaval, Inc. | 08/16/1985SE |
| K851987 | Flush Device, AutomaticDRS · Traditional | Transamerica Delaval, Inc. | 08/16/1985SE |
| K851888 | Apm Dispos. Blood Pressure TransducerDRS · Traditional | Honeywell, Inc. | 08/06/1985SE |
| K850898 | Medi-Trace Disposable Pressure TransducerDRS · Traditional | Medi-Trace Products Division | 07/25/1985SE |
| K843273 | Dispos. Pressure Kit 1295K SeriesDRS · Traditional | Hewlett-Packard Co. | 06/11/1985SE |
| K843580 | Medi-Trace Transduc Phys Pressure MonitoDRS · Traditional | Graphic Controls Corp. | 05/28/1985SE |
| K842352 | Pressure Monitoring KitDRS · Traditional | Utah Medical Products, Inc. | 03/25/1985SE |
| K841788 | Utah Disposable Pressure TransducerDRS · Traditional | Utah Medical Products, Inc. | 03/25/1985SE |
| K841613 | Pressure Transducer Dome 1295CDRS · Traditional | Hewlett-Packard Co. | 10/24/1984SE |
| K833171 | Monitoring KitDRS · Traditional | Transamerica Delaval, Inc. | 09/06/1984SE |
| K833170 | Flush DeviceDRS · Traditional | Transamerica Delaval, Inc. | 08/12/1984SE |
| K841968 | Deseret Disposable Pressure TransducerDRS · Traditional | Parke-Davis Co. | 08/06/1984SE |
| K840023 | Trantec Physiological Pressure TransducDRS · Traditional | American Bentley | 06/22/1984SE |
| K840121 | Physiological Pressure Transducer 1290CDRS · Traditional | Hewlett-Packard Co. | 05/16/1984SE |
| K840274 | Cardiofax ECG 6543DRS · Traditional | Nihon Kohden America, Inc. | 04/17/1984SE |
| K832897 | Model TTPM Time Temp. Pressure MonitorDRS · Traditional | Electromedics, Inc. | 03/22/1984SE |
| K833792 | Trantecsilicone Quartz Disp. TransdDRS · Traditional | American Bentley | 02/10/1984SE |
| K832907 | Invasive Monitoring KitsDRS · Traditional | American Pharmaseal Div. Ahsc | 01/10/1984SE |
| K833271 | Namic Continuous Flush DeviceDRS · Traditional | North American Instrument Corp. | 12/01/1983SE |
| K832657 | Disposable Manifold SetDRS · Traditional | Mallinckrodt Critical Care | 11/07/1983SE |
| K833096 | Transducer Dome DS106DRS · Traditional | Sorensen Research | 11/03/1983SE |
| K833095 | Transducer Dome SD105DRS · Traditional | Sorensen Research | 11/03/1983SE |
| K833094 | Transducer Dome SD104DRS · Traditional | Sorensen Research | 11/03/1983SE |
| K831867 | Pressure Monitoring IV Bottle CapDRS · Traditional | Alto Development Corp. | 08/12/1983SE |
| K831506 | Disp. Transducer W/Monitoring Kit TransDRS · Traditional | Sorensen Research | 08/12/1983SE |
| K831698 | Disposable Pressure TRANSDUCER#14004195DRS · Traditional | Norton Performance Plastics Corp. | 08/11/1983SE |
| K831348 | Fluid Admin. Set AFS-1CDRS · Traditional | Linton Biomed Corp. | 05/27/1983SE |
| K830210 | Disposable Pressure TransducerDRS · Traditional | American Pharmaseal Div. Ahsc | 04/18/1983SE |
| K823334 | Physiological Press. Transducer PCM3630DRS · Traditional | Psitron | 03/24/1983SE |
| K830093 | Usci Electronic ManometerDRS · Traditional | C.R. Bard, Inc. | 01/28/1983SE |
| K823286 | Models DPT 1000/DPT 1000NSDRS · Traditional | Bio-Med Corp. | 12/30/1982SE |
| K822507 | Disposable Transducer & AccessoriesDRS · Traditional | Gould, Inc. | 09/14/1982SE |
| K821894 | Disposable Transducer Domes & KitsDRS · Traditional | American Pharmaseal Div. Ahsc | 07/20/1982SE |
| K821416 | Disposable Blood Pressure TransducerDRS · Traditional | Bentley Laboratories, Inc. | 07/02/1982SE |
| K820459 | Viragard/VirashieldDRS · Traditional | Tri-Med, Inc. | 06/16/1982SE |
| K821450 | Pressure Tubing-Adult & PediatricDRS · Traditional | Gould, Inc. | 05/25/1982SE |
| K820579 | FLEX-E1 ECG ElectrodeDRS · Traditional | Conmedcorp | 04/14/1982SE |
| K820677 | Touch Flush Continuous Fast/FlushDRS · Traditional | Norton Performance Plastics Corp. | 03/25/1982SE |
| K820676 | Touch Flush W/Y Transducer ConnectorDRS · Traditional | Norton Performance Plastics Corp. | 03/25/1982SE |
| K820457 | Medi-Trace Physiological Pressure TransDRS · Traditional | Graphic Controls Corp. | 03/12/1982SE |
| K820355 | Disposable Diaphragm DomesDRS · Traditional | Medex, Inc. | 03/04/1982SE |
| K820342 | Physiological Pressure Transducer #900DRS · Traditional | Bentley Laboratories, Inc. | 03/04/1982SE |
| K820202 | Continuous Flush Device/FdiDRS · Traditional | Linton Biomed Corp. | 02/12/1982SE |
| K820201 | Dispos. Monitoring Sys/Li Et AlDRS · Traditional | Linton Biomed Corp. | 02/12/1982SE |
| K820186 | Bard Cardiopulmonary Monitoring LinesDRS · Traditional | C.R. Bard, Inc. | 02/12/1982SE |
| K820046 | Anesthesiology DevicesDRS · Traditional | Bentley Laboratories, Inc. | 01/29/1982SE |
| K813266 | Nihon Kohden ElectrocardiographDRS · Traditional | Nihon Kohden America, Inc. | 01/29/1982SE |
| K813549 | Continuous Flush DeviceDRS · Traditional | Namic | 01/12/1982SE |
| K813464 | Disposable TransducerDRS · Traditional | Sorensen Research | 01/07/1982SE |
| K813502 | Narco Telecare Isoflo Pressure MonitorDRS · Traditional | Narco Bio-Systems | 12/29/1981SE |
| K813267 | Disposable Diaphragm DomesDRS · Traditional | Dio-Med Corp. | 12/14/1981SE |
| K813137 | Correc Torr TMDRS · Traditional | Norton Performance Plastics Corp. | 12/02/1981SE |
| K813053 | Disposable Blood Pressure Transducer DomDRS · Traditional | Bentley Laboratories, Inc. | 11/16/1981SE |
| K812884 | Narco Telecare Pressure Transducer DomeDRS · Traditional | Narco Scientific | 11/02/1981SE |
| K812883 | Telecare Isotec Pressure Transducer DomeDRS · Traditional | Narco Scientific | 11/02/1981SE |
| K812758 | Physiological Pressure TransducerDRS · Traditional | Electromedics, Inc. | 10/20/1981SE |
| K812530 | Transducer DomeDRS · Traditional | Biomeal Corp. | 10/13/1981SE |
| K811980 | Electronic Blood Pressure Transducer ManDRS · Traditional | H.R. Biomedical, Ltd. | 07/28/1981SE |
| K811538 | Models Ta 1017 & 1017T Gritiflo DisposDRS · Traditional | Gould, Inc. | 06/12/1981SE |
| K810735 | Disposable, Sterile Transducer DomesDRS · Traditional | Bio-Med Corp. | 05/08/1981SE |
| K810637 | Cobe Disposable Pressure TransducerDRS · Traditional | Cobe Laboratories, Inc. | 04/23/1981SE |
| K810661 | CathdampDRS · Traditional | Medline Industries, Inc. | 03/27/1981SE |
| K810431 | Narco Tlecare Miniature Pressure DomeDRS · Traditional | Narco Bio-Systems | 03/11/1981SE |
| K810009 | Disposable Diaphragm DomeDRS · Traditional | Medex, Inc. | 02/19/1981SE |
| K803096 | Narco Telecare Transducer Dome #700-4000DRS · Traditional | Narco Scientific | 01/13/1981SE |
| K802179 | Cardioscope J200DRS · Traditional | Telectronics, Inc. | 11/12/1980SE |
| K802069 | Disp. Transducer Domes TD200 & TD300DRS · Traditional | Bio-Med Corp. | 09/09/1980SE |
| K801985 | Bio-Med Corp. Disp. Non-Sterile TransduDRS · Traditional | Bio-Med Corp. | 09/09/1980SE |
| K801239 | Sterile, Disp Dome, Individ. Pkg.DRS · Traditional | Pacific Domes, Inc. | 07/14/1980SE |
| K801138 | Model P-380 Physiological Pressure Tran.DRS · Traditional | Gics Pharmaceuticals | 07/14/1980SE |
| K801136 | D300 DomeDRS · Traditional | Gics Pharmaceuticals | 06/20/1980SE |
| K801048 | AccudynamicDRS · Traditional | Sorensen Research | 05/14/1980SE |
| K800706 | Medi-Trace Disposable Domes/MonitoringDRS · Traditional | Graphic Controls Corp. | 04/16/1980SE |
| K800705 | Medi-Trace Transducers/Physiolog. MonitoDRS · Traditional | Graphic Controls Corp. | 04/16/1980SE |
| K792020 | Ae 840 Physiological Pressure TransducerDRS · Traditional | Life Medical Services, Inc. | 12/07/1979SE |
| K792073 | Model 1979 Blood Pressurometer R CharterDRS · Traditional | Del Mar Avionics | 11/05/1979SE |
| K791636 | AccunamicDRS · Traditional | Sorensen Research | 10/04/1979SE |
| K790407 | Microtec Bacterial FilterDRS · Traditional | Medex, Inc. | 05/16/1979SE |
| K781680 | Monitoring, Pressure KitDRS · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 10/06/1978SE |
| K780797 | Transducer, Pressure, Option, H-P, P23IDDRS · Traditional | Gould, Inc. | 06/13/1978SE |
| K780477 | Physiological Pressure TransducerDRS · Traditional | Bell & Howell Instruments | 04/13/1978SE |
| K780128 | Blood Pressure Monitor, ArterialDRS · Traditional | Applied Medical Research | 01/31/1978SE |
| K780127 | Dinamap Model 850DRS · Traditional | Applied Medical Research | 01/31/1978SE |
| K771668 | Disp. Fluid Isolator & Press. ReliefDRS · Traditional | Ailtech | 09/14/1977SE |
| K771361 | Physiological Pressure Transducer 1290ADRS · Traditional | Hewlett-Packard Co. | 08/04/1977SE |
| K761325 | Model DA-53 Pressure Guage IsolatorDRS · Traditional | Extracorporeal Medical Specialities, Inc. | 01/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2142-2026 Class I | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2141-2026 Class I | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-1429-2025 Class II | namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit…The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near… | MEDLINE INDUSTRIES, LP - Northfield | 02/12/2025Open, Classified |
| Z-0747-2024 Class II | 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694RThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0746-2024 Class II | Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682RThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0745-2024 Class II | 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BRThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0744-2024 Class II | HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HPThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0743-2024 Class II | HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HPThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0742-2024 Class II | Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331RThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0741-2024 Class II | 6IN PRESSURE TUBING, List Number MX20617There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0740-2024 Class II | 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRLThere is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0739-2024 Class II | Medex LOGICAL CATH LAB KIT, List Number M20754There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter… | Smiths Medical Asd Inc | 11/10/2023Open, Classified |
| Z-0414-2024 Class II | TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm)…Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure… | Edwards Lifesciences, LLC | 10/04/2023Open, Classified |
| Z-0413-2024 Class II | TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm)…Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure… | Edwards Lifesciences, LLC | 10/04/2023Open, Classified |
| Z-0412-2024 Class II | FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For…Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure… | Edwards Lifesciences, LLC | 10/04/2023Open, Classified |
| Z-0411-2024 Class II | FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For…Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure… | Edwards Lifesciences, LLC | 10/04/2023Open, Classified |
| Z-0410-2024 Class II | Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use…Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure… | Edwards Lifesciences, LLC | 10/04/2023Open, Classified |
| Z-0409-2024 Class II | Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only…Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure… | Edwards Lifesciences, LLC | 10/04/2023Open, Classified |
| Z-1481-2021 Class II | Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1480-2021 Class II | Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1479-2021 Class II | HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1478-2021 Class II | HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1477-2021 Class II | Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1476-2021 Class II | Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1473-2021 Class II | LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1471-2021 Class II | Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1470-2021 Class II | LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood…Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal… | Smiths Medical ASD Inc. | 03/31/2021Terminated |
| Z-1072-2019 Class II | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port…Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots… | ICU Medical, Inc. | 11/27/2018Terminated |
| Z-1071-2019 Class II | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port…Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots… | ICU Medical, Inc. | 11/27/2018Terminated |
| Z-1070-2019 Class II | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port…Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots… | ICU Medical, Inc. | 11/27/2018Terminated |
| Z-0296-2020 Class II | Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0295-2020 Class II | Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0294-2020 Class II | Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0293-2020 Class II | (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0292-2020 Class II | Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0291-2020 Class II | Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0290-2020 Class II | (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0289-2020 Class II | Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0288-2020 Class II | (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male…The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the… | Argon Medical Devices, Inc | 10/16/2018Terminated |
| Z-0575-2017 Class II | LEFT HEART KIT, Item No. AG8052-NS The Transpac Disposable Straight Pressure Transducer…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0574-2017 Class II | CATH LAB KIT W/3 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE & TP4, Item No. AG7891-NS The…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0573-2017 Class II | Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 The Transpac Disposable…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0572-2017 Class II | 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS The Transpac…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0571-2017 Class II | Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste Bag System…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0570-2017 Class II | Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 cc…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0569-2017 Class II | Transpac IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device, PT Tubings, 3-Way…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0568-2017 Class II | Transpac IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0567-2017 Class II | Transpac IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No.…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0566-2017 Class II | Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |
| Z-0565-2017 Class II | Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush…ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits… | ICU Medical, Inc. | 09/27/2016Terminated |