Medrad, Inc.
Valhalla, NY, US
Medrad, Inc. appears in FDA device records in Valhalla, NY. FDA records list 177 510(k) clearances between and , 7 PMA records and 8 registered establishments. As of , FDA records show 55 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
7 namesFDA records resolved to Medrad, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ascensia Diabetes Care US Inc.registration, 510(k), enforcement report, recall
- BAYER HEALTHCARE LLC, CONSUMER CAREregistration
- Bayer HealthCare LLC, Diagnostics Divrecall
- Bayer HealthCare, LLCregistration, 510(k), PMA, enforcement report, recall
- Bayer Medical Care Inc.registration, 510(k), enforcement report, recall
- Medrad Inc dba Bayer R&Ienforcement report, recall
- Medrad Mr Incenforcement report, recall
510(k) clearance history
Showing 50 of 177FDA records hold 177 510(k) clearances for Medrad, Inc. between 1976 and 2026. The busiest year on record is 2003, with 19. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 1 |
| 1987 | 2 |
| 1988 | 7 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 6 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 5 |
| 1998 | 10 |
| 1999 | 5 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 19 |
| 2004 | 8 |
| 2005 | 17 |
| 2006 | 9 |
| 2007 | 3 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 7 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | PQH | Substantially Equivalent | |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | DXT | Substantially Equivalent | |
| K250893 | Ball Joint Guide Array (66295) | HAW | Substantially Equivalent | |
| K250813 | MICROLET®NEXT 2 Lancing Device | QRL | Substantially Equivalent | |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K241810 | MICROLET®NEXT Lancet | QRK | Substantially Equivalent | |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | QRL | Substantially Equivalent | |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | PQH | Substantially Equivalent | |
| K192370 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation | DXT | Substantially Equivalent | |
| K193028 | MEDRAD Mark 7 Arterion Injection System | DXT | Substantially Equivalent | |
| K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | DXT | Substantially Equivalent | |
| K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | Substantially Equivalent | |
| K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | Substantially Equivalent | |
| K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | NUH | Substantially Equivalent | |
| K162336 | Contour Next EZ Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | NUH | Substantially Equivalent | |
| K150942 | Contour Next USB Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K151742 | Contour Next Control Solution | JJX | Substantially Equivalent | |
| K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | DXT | Substantially Equivalent | |
| K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | MCW | Substantially Equivalent | |
| K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER | NBW | Substantially Equivalent | |
| K122370 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR | NBW | Substantially Equivalent | |
| K130381 | ANGIOJET ULTRA POWER PULSE KIT | QEW | Substantially Equivalent | |
| K130637 | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM | MCW | Substantially Equivalent | |
| K122916 | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM | MCW | Substantially Equivalent | |
| K121190 | CONTOUR NEXT BLOOD GLUCOSE METER | LFR | Substantially Equivalent | |
| K121087 | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | QEZ | Substantially Equivalent | |
| K110894 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER | LFR | Substantially Equivalent | |
| K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) | LFR | Substantially Equivalent | |
| K111268 | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM | LFR | Substantially Equivalent | |
| K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | DXT | Substantially Equivalent | |
| K113428 | ANGIOJET ULTRA DVX THROMBECTOMY SET | QEZ | Substantially Equivalent | |
| K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | DXT | Substantially Equivalent | |
| K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | QEZ | Substantially Equivalent | |
| K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | FRN | Substantially Equivalent | |
| K093930 | DIDGET WORLD REPORTS | NBW | Substantially Equivalent | |
| K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 | NBW | Substantially Equivalent | |
| K091820 | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM | NBW | Substantially Equivalent | |
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC | LCP | Substantially Equivalent | |
| K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC | DXT | Substantially Equivalent | |
| K082458 | P3T ABDOMEN | JAK | Substantially Equivalent | |
| K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | |
| K080297 | MEDRAD INTEGO PET INFUSION SYSTEM | FRN | Substantially Equivalent | |
| K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY | FRN | Substantially Equivalent | |
| K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T | DXT | Substantially Equivalent | |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | JFM | Substantially Equivalent | |
| K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | IZQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1810909 | 1810909 | Ascensia Diabetes Care US Inc. | 100 Summit Lake Drive, Valhalla, NY 10595 US | 2026 | |
| 3011121740 | 3010700165 | Ascensia Diabetes Care US Inc. | 5 Wood Hollow Road, Parsippany, NJ 07054 US | 2026 | |
| 2248903 | 3000206585 | BAYER HEALTHCARE LLC, CONSUMER CARE | 36 Columbia Rd, MORRISTOWN, NJ 07960 US | 2026 | |
| 2243252 | 2243252 | Bayer HealthCare, LLC | 36 Columbia Rd, Morristown, NJ 07960 US | 2026 | |
| 3012469182 | 3012469182 | Bayer Medical Care B.V. | Avenue Ceramique 27, Maastricht Limburg 6221 KV NL | 2026 | |
| 2520313 | 2520313 | Bayer Medical Care Inc. | 1 Bayer Drive, INDIANOLA, PA 15051 US | 2026 | and 5 more, listed in full below |
| 3004056159 | 3004056159 | Bayer Medical Care Inc. | 625 Alpha Dr, Pittsburgh, PA 15238 US | 2026 | |
| 3006791331 | 3006791331 | Bayer Medical Care Inc. | 150 Victory Road, Saxonburg, PA 16056 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- NDWAssay, Porphyrin, Spectrophotometry, Lithium
- KQOAutomated Urinalysis System
- JQPCalculator/Data Processing Module, For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- DQOCatheter, Intravascular, Diagnostic
- MCWCatheter, Peripheral, Atherectomy
- EAGCephalometer
- MOSCoil, Magnetic Resonance, Specialty
- LHEController, Closed-Loop Blood Glucose
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- DREDilator, Vessel, For Percutaneous Catheterization
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JFMEnzymatic Method, Bilirubin
- JJTEnzyme Controls (Assayed And Unassayed)
- KLTEnzyme Immunoassay, Carbamazepine
- LEGEnzyme Immunoassay, Valproic Acid
- LFRGlucose Dehydrogenase, Glucose
- LOLHepatitis A Test (Antibody And Igm Antibody)
- CFRHexokinase, Glucose
- MMIImmunoassay Method, Troponin Subunit
- DXTInjector And Syringe, Angiographic
- IZQInjector, Contrast Medium, Automatic
- KZHIntroducer, Syringe Needle
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KCONasal Spray, Ent Delivery
- GDMNeedle, Aspiration And Injection, Reusable
- HAWNeurological Stereotaxic Instrument
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- IMDPack, Hot Or Cold, Disposable
- IZPProgrammer, Changer, Film/Cassette, Radiographic
- LTJProstate-Specific Antigen (Psa) For Management Of Prostate Cancers
- FRNPump, Infusion
- CDDRadioassay, Vitamin B12
- DOYRadioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FOXStand, Infusion
- IXOSynchronizer, Ecg / Respirator, Radiographic
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- NBWSystem, Test, Blood Glucose, Over The Counter
- NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- KPRSystem, X-Ray, Stationary
- JAKSystem, X-Ray, Tomography, Computed
- KGXTape And Bandage, Adhesive
- NBCTest, Natriuretic Peptide
- HHSTranscervical Contraceptive Tubal Occlusion Device
- FPKTubing, Fluid Delivery
- DWETubing, Pump, Cardiopulmonary Bypass
- JJWUrinalysis Controls (Assayed And Unassayed)
- JHIVisual, Pregnancy Hcg, Prescription Use
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 55| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2296-2026 | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648; | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption. | Class II | Open, Classified | |
| Z-2211-2023 | Contour next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention. | Class II | Open, Classified | |
| Z-0910-2023 | Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures. | Black specks may be present on the packaged needles | Class II | Open, Classified | |
| Z-0199-2022 | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system. | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) | Class II | Terminated | |
| Z-0483-2021 | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube. | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. | Class II | Terminated | |
| Z-0745-2019 | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL (58-S, 58-P, 85-S, 85-P, 100-S, 100-P, 70Si, 97Si), OCS TRACK (58-S, 58-P, 80-S, 80-P), OCS WALL (S, P), OCS (115A, 115CT, 125CT, 125A, 135A, 135CT, 145, 155A, 165A, 115AS, 115CTS), EOC (700, 700S), EOW 700, EOA 700 | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. | Class II | Terminated | |
| Z-0097-2019 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path. | Class II | Terminated | |
| Z-2962-2018 | Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765 | The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator. | Class II | Terminated | |
| Z-2960-2018 | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 | The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator. | Class II | Terminated | |
| Z-2961-2018 | Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288 | The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator. | Class II | Terminated | |
| Z-0927-2017 | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures. | Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted. | Class II | Terminated | |
| Z-0400-2017 | PET Infusion Pump | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date. | Class II | Terminated | |
| Z-2768-2016 | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. | Class II | Terminated | |
| Z-2244-2016 | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device. | Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. | Class II | Terminated | |
| Z-0627-2016 | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. | The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an RP prime fail | Class II | Terminated | |
| Z-2775-2015 | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. | Class II | Terminated | |
| Z-2482-2015 | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples. | If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low. | Class II | Terminated | |
| Z-0810-2014 | Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor. | The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor. | Class II | Terminated | |
| Z-1686-2015 | MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. | The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion. | Class II | Terminated | |
| Z-0136-2014 | Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes. | Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release. | Class II | Terminated | |
| Z-1586-2013 | DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient | The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. | Class II | Terminated | |
| Z-0870-2013 | MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients. | The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory. | Class II | Terminated | |
| Z-0605-2013 | 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 therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. | Class II | Terminated | |
| Z-0604-2013 | 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. | Class II | Terminated | |
| Z-0603-2013 | 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain