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Abbott Medical

Burlington, MA, US

Abbott Medical appears in FDA device records in Burlington, MA. FDA records list 1,478 510(k) clearances between and , 5,012 PMA records and 40 registered establishments. As of , FDA records show 2,479 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1,478
PMA records
5,012
Recall records
2,479
Registered establishments
40

FDA records under these names

39 names

FDA records resolved to Abbott Medical 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.

  • Abbott Diabetes Care, Inc.registration, 510(k), PMA, enforcement report, recall
  • Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CArecall
  • Abbott GmBH & Co. KGenforcement report, recall
  • Abbott Laboratories Diagnostic Divrecall
  • Abbott Laboratories HPD/ADDrecall
  • Abbott Laboratories HPD/ADD/GPRDrecall
  • Abbott Laboratories Inc. (St Jude Medical)enforcement report, recall
  • Abbott Laboratories Medisense Productsrecall
  • Abbott Laboratories MPGrecall
  • Abbott Laboratories, Inc.registration, 510(k), PMA, enforcement report, recall
  • Abbott Point of Care, Inc.registration, 510(k), enforcement report, recall
  • Abbott S.r.l.registration, 510(k), PMA, enforcement report, recall
  • Advanced Neuromodulation Systems510(k), enforcement report, recall
  • Aga Medical Corporation510(k), recall
  • Deltec, Inc.510(k), recall
  • Ep Medsystems, Inc.510(k), recall
  • Hospira Inc., A Pfizer Companyenforcement report, recall
  • Hospira, Inc.registration, 510(k), PMA, enforcement report, recall
  • ICUrecall
  • Icu Medical, Inc.registration, 510(k), enforcement report, recall
  • Laborie Medical Technologies Correcall
  • Laborie Medical Technologies, Ltd.registration, 510(k), enforcement report, recall
  • Labories Medical Technologiesenforcement report, recall
  • Portex, Inc.510(k), recall
  • Sims Portex, Inc.510(k), recall
  • Smiths Medical510(k), recall
  • Smiths Medical Asd, Inc.510(k), PMA, enforcement report, recall
  • Smiths Medical International , Ltd.510(k), recall
  • Smiths Medical MD, Inc.510(k), recall
  • Smiths Medical Pm, Inc.510(k), recall
  • St Jude Medical, Crmd510(k), recall
  • St. Jude Medicalregistration, 510(k), PMA, enforcement report, recall
  • St. Jude Medical Cardiovascular Divisionrecall
  • St. Jude Medical, Atrial Fibrillation Division, Inc.registration, enforcement report, recall
  • St. Jude Medical, Cardiac Rhythm Management Divisionenforcement report, recall
  • St. Jude Medical, Cardian Rhythm Management Divisionenforcement report, recall
  • St. Jude Medical, Cardiology Division, Inc.registration
  • St. Jude Medical, Daig Division, Inc.510(k), recall
  • Thoratec Corporationregistration, 510(k), PMA, enforcement report, recall

510(k) clearance history

Showing 50 of 1,478

FDA records hold 1,478 510(k) clearances for Abbott Medical between 1976 and 2026. The busiest year on record is 1998, with 74. The most recent is 2026, with 15.

Clearances by year, as a table
510(k) clearance decisions for Abbott Medical, by decision year
YearClearances
19765
197733
197816
197926
198031
198126
198219
198338
198434
198542
198641
198741
198855
198951
199037
199128
199227
199320
199445
199547
199628
199722
199874
199929
200024
200119
200235
200334
200438
200530
200644
200740
200841
200941
201026
201118
201225
201319
201417
201520
201621
201717
201816
201910
202014
202114
202215
202329
202417
202524
202615
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K262006EnSite™ X EP SystemDQKSubstantially Equivalent
K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQYSubstantially Equivalent
K261039i-STAT Crea cartridge with the i-STAT 1 SystemCGLSubstantially Equivalent
K261631Amplatzer TorqVue Exchange SystemDQYSubstantially Equivalent
K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMISubstantially Equivalent
K252424Anti-HCV NextMZOSubstantially Equivalent
K260993Amplatzer TorqVue Delivery SystemDQYSubstantially Equivalent
K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)NQQSubstantially Equivalent
K260212EnSite™ X EP SystemDQKSubstantially Equivalent
K253907Disposable Radiofrequency CannulaGXISubstantially Equivalent
K252130LifeShield Infusion Safety Software SuitePHCSubstantially Equivalent
K252006OTTO™ Disinfecting CapQBPSubstantially Equivalent
K251980ClaveQS™ BagKPESubstantially Equivalent
K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQYSubstantially Equivalent
K252512Armada™ 14 NC PTA CatheterLITSubstantially Equivalent
K253516Assert-IQ (DM5100)MXDSubstantially Equivalent
K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)DQYSubstantially Equivalent
K253232Seguin Annuloplasty RingKRHSubstantially Equivalent
K250031Amplatzer GuidewireDQXSubstantially Equivalent
K252013EnSite™ X EP SystemDQKSubstantially Equivalent
K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXDSubstantially Equivalent
K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)DQKSubstantially Equivalent
K251234EnSite™ X EP SystemDQKSubstantially Equivalent
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQXSubstantially Equivalent
K243500ARCHITECT iGentamicinLCDSubstantially Equivalent
K243168Alinity i Rubella IgGLFXSubstantially Equivalent
K250616Clave™ Neutral-Displacement Needlefree ConnectorsFPASubstantially Equivalent
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)GXISubstantially Equivalent
K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJSubstantially Equivalent
K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJSubstantially Equivalent
K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemCHLSubstantially Equivalent
K250426Amulet™ Steerable Delivery SheathDQYSubstantially Equivalent
K243549JETi Hydrodynamic Thrombectomy SystemQEZSubstantially Equivalent
K242117LifeShield Infusion Safety Software SuitePHCSubstantially Equivalent
K242115Plum Duo™ Precision IV PumpFRNSubstantially Equivalent
K242114Plum Solo™ Precision IV PumpFRNSubstantially Equivalent
K243283Alinity h-series SystemGKZSubstantially Equivalent
K243985Rio™ Drug Reconstitution Transfer DeviceLHISubstantially Equivalent
K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMISubstantially Equivalent
K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)DQYSubstantially Equivalent
K243493Agilis NxT Steerable Introducer Dual-ReachDYBSubstantially Equivalent
K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQXSubstantially Equivalent
K233932Alinity i Toxo IgMLGDSubstantially Equivalent
K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)FBKSubstantially Equivalent
K241538TriClip Steerable Guide CatheterDQYSubstantially Equivalent
K242016EnSite™ X EP SystemDQKSubstantially Equivalent
K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™MTDSubstantially Equivalent
K241370Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)DYBSubstantially Equivalent
K233861Libre Rio Continuous Glucose Monitoring SystemSBHSubstantially Equivalent
K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeQNQSubstantially Equivalent

Registered establishments

FDA registered establishments for Abbott Medical, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29543233002803444ABBOTT DIABETES CARE INC.1360 SOUTH LOOP RD., ALAMEDA, CA 94502 US2026and 7 more, listed in full below
97104923003500908ABBOTT DIABETES CARE LIMITEDRANGE RD., WITNEY OXON Oxfordshire OX29 0YL GB2026
30028091443002809144ABBOTT GmbHMax-Planck-Ring 2, Wiesbaden Hesse 65205 DE2026and 127 more, listed in full below
14159391415939ABBOTT LABORATORIES100 ABBOTT PARK RD., Abbott Park, IL 60064 US2026and 6 more, listed in full below
14519141451914ABBOTT LABORATORIESU.S. 41/MARTIN LUTHER KING DR., North Chicago, IL 60064 US2026No device listings on this registration
16286641628664ABBOTT LABORATORIES1921 Hurd Dr, IRVING, TX 75038 US2026
29190692919069ABBOTT LABORATORIES647 Almanor Ave., Sunnyvale, CA 94085 US2026
30053333583005333358ABBOTT LABORATORIESConway Park, Lake Forest, IL 60045 US2026and 182 more, listed in full below
30164387613016438761ABBOTT LABORATORIES1915 Hurd Drive, Irving, TX 75038 US2026and 61 more, listed in full below
20178652017865ABBOTT MEDICAL15900 Valley View Court, Sylmar, CA 91342 US2026and 23 more, listed in full below
30132882013013288201ABBOTT MEDICAL14901 Deveau Pl. Building 2, Minnetonka, MN 55345 US2026and 12 more, listed in full below
22455782245578ABBOTT POINT OF CARE INC.400 College Road East, Princeton, NJ 08540 US2026and 12 more, listed in full below
16274871627487Abbott Medical6901 Preston Rd, PLANO, TX 75024 US2026and 4 more, listed in full below
21351473005334138Abbott Medical5050 NATHAN LANE NORTH, Plymouth, MN 55442 US2026and 12 more, listed in full below
26486122648612Abbott MedicalLOT 20 B Street, Caguas, PR 00725 US2026
30049361103004936110Abbott Medical387 Nerem St Nw Ste 500, Atlanta, GA 30313 US2026
30067058153006705815Abbott MedicalLOT A INTERIOR - No. 2 RD KM 67.5, Arecibo, PR 00612 US2026and 11 more, listed in full below
30071134873007113487Abbott Medical177 County Road B East, Saint Paul, MN 55117 US2026and 11 more, listed in full below
30084943153008377825Abbott MedicalPlot 102, Lebuhraya Kampung Jawa, Penang Pulau Pinang 11900 MY2026and 5 more, listed in full below
30096000983009600098Abbott Medical4 Robbins Rd, Westford, MA 01886 US2026
30117067993011706799Abbott Medical1850 MacArthur Blvd NW, Atlanta, GA 30318 US2026
30209508183020950818Abbott Medical1820 Bastian Court, Westfield, IN 46074 US2026
30040320533004032053Abbott S.r.l.Viale Thomas Alva Edison, 110, Milan Lombardy 20099 IT2026
19252621925262HOSPIRA, INC.1776 NORTH CENTENNIAL DR., MCPHERSON, KS 67460 US2026
17134681713468ICU MEDICAL, INC4455 ATHERTON DR., Salt Lake City, UT 84123 US2026and 18 more, listed in full below
20240642024064ICU MEDICAL, INC.13520 EVENING CREEK DRIVE NORTH, SAN DIEGO, CA 92128 US2026
20258162025816ICU MEDICAL, INC.951 CALLE AMANECER, SAN CLEMENTE, CA 92673 US2026and 82 more, listed in full below
30133192123013319212ICU MEDICAL, INC.600 N Field Dr, Lake Forest, IL 60045 US2026and 22 more, listed in full below
12196111219611ICU Medical, Inc.201 W Queen St, SOUTHINGTON, CT 06489 US2026
15268631526863ICU Medical, Inc.6250 Shier Rings Rd, DUBLIN, OH 43016 US2026and 30 more, listed in full below
30088189803008818980ICU Medical, Inc.9124 Polk Lane, Suite 101, Olive Branch, MS 38654 US2026
30275791753027579175ICU Medical, Inc.2625 Main St, Highland, IN 46322 US2026
30174483603017448360LABORIE MEDICAL TECHNOLOGIES CORP.180 International Drive, Portsmouth, NH 03801 US2026and 4 more, listed in full below
30121797283012179728St. Jude Medical2305 Walnut Street, Roseville, MN 55113 US2026and 22 more, listed in full below
21822692182269St. Jude Medical, Atrial Fibrillation Division, Inc.14901 DEVEAU PL., Minnetonka, MN 55345 US2026and 5 more, listed in full below
21841491000139754St. Jude Medical, Atrial Fibrillation Division, Inc.One St. Jude Medical Drive, Saint Paul, MN 55117 US2026and 7 more, listed in full below
30053341383005334138St. Jude Medical, Cardiology Division, Inc.5050 Nathan Lane North, Plymouth, MN 55442 US2026and 33 more, listed in full below
12184441218444THORATEC CORP23 4th Ave, BURLINGTON, MA 01803 US2026
29165962916596THORATEC CORP.6035 Stoneridge Dr, PLEASANTON, CA 94588 US2026and 1 more, listed in full below
30087926573008792657Thoratec Corporation4550 Norris Canyon Rd, San Ramon, CA 94583 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 2,479
Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2759-2026Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.Class IIOpen, Classified
Z-2724-2026ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.Class IIOpen, Classified
Z-2723-2026ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.Class IIOpen, Classified
Z-2669-2026Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.Class IIOpen, Classified
Z-2520-2026Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System ControllerDue to 11 volt Backup Battery failures.Class IIOpen, Classified
Z-2519-2026Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) KitsDue to 11 volt Backup Battery failures.Class IIOpen, Classified
Z-2518-2026Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: NoDue to 11 volt Backup Battery failures.Class IIOpen, Classified
Z-2405-2026Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareSoftware malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.Class IIOpen, Classified
Z-2313-2026Plum Duo Precision IV Pump, 40002-0403Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.Class IIOpen, Classified
Z-2312-2026Plum Duo Infusion Pump, 40002-0401Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.Class IIOpen, Classified
Z-2311-2026Plum Solo Precision IV Pump, 40001-0401Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.Class IIOpen, Classified
Z-2001-2026i-STAT G3+ cartridge; List Number: 03P78-26;Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.Class IIOpen, Classified
Z-2000-2026i-STAT EG6+ cartridge; List Number: 03P77-25;Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.Class IIOpen, Classified
Z-1999-2026i-STAT EG7+ cartridge; List Number: 03P76-25;Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.Class IIOpen, Classified
Z-2210-2026Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.Class IIOpen, Classified
Z-1101-2026Portex Spinal Tray, Item No. A3729-24 A3595Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.Class IIOpen, Classified
Z-1100-2026Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PGAffected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.Class IIOpen, Classified
Z-1111-2026Tego 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 intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the bodyClass IIOpen, Classified
Z-1094-2026Plum Duo Infusion System, List Number 40002-04-01ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.Class IIOpen, Classified
Z-1120-2026ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.Class IIOpen, Classified
Z-1119-2026ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.Class IIOpen, Classified
Z-1118-2026ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.Class IIOpen, Classified
Z-1023-2026FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose resultsClass IOpen, Classified
Z-1022-2026FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose resultsClass IOpen, Classified
Z-1021-2026FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose resultsClass IOpen, Classified

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