Data / Medical devices / United States / CareFusion 303, INC.
CareFusion 303, INC.: FDA-registered device maker in San Diego, CA, United States, 11 510(k) clearances
CareFusion 303, INC. is registered with the FDA (registration 2016493) in San Diego, CA, United States. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 25, 2025. 106 recall events name it as the recalling firm (22 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2016493
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, United States, 92121
- Owner or operator
- CareFusion 303, INC. (9068764)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 10, 2007
- Registered through
- 2026
- Brand names listed
- Alaris PC Unit, Alaris PCA, Alaris System with Guardrails Suite MX, Alaris System with MMS, Alaris/Medley Bar Code Module, Alaris/Medley EtCO2 Module, Alaris/Medley SpO2 Module, Alaris/Medley Syringe Module and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cabinet, Table And Tray, Anesthesia | BRY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Infusion Safety Management Software | PHC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Pca | MEA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 25, 2025 | K243855 | BD Alaris Infusion System with Guardrails Suite MX | FRN | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| July 21, 2023 | K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | FRN | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| August 21, 2014 | K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX | FRN | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| December 28, 2007 | K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX | FRN | Substantially Equivalent | Cardinal Health 303,Inc. | accessdata.fda.gov |
| October 20, 2005 | K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 | FRN | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| December 10, 2004 | K043299 | MEDLEY PCA MODULE, MODEL 8120 | MEA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| July 6, 2004 | K041241 | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 | FRN | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| February 9, 2004 | K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | CCK | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| December 19, 2002 | K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | FRN | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| September 11, 2002 | K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE | DQA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| June 8, 2001 | K010966 | MEDLEY SP02 MODULE, MODEL 8220 | DQA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 106.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | 98895 | Class II | Ongoing | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | accessdata.fda.gov |
| February 11, 2026 | 98250 | Class II | Ongoing | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units | accessdata.fda.gov |
| December 3, 2025 | 97546 | Class II | Ongoing | BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 13 | Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. | accessdata.fda.gov |
| November 20, 2025 | 97712 | Class II | Ongoing | BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure T | Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stor | accessdata.fda.gov |
| November 6, 2025 | 97871 | Class II | Ongoing | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids | Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network | accessdata.fda.gov |
| October 17, 2025 | 97669 | Class I | Ongoing | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection | If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting proce | accessdata.fda.gov |
| September 30, 2025 | 97566 | Class II | Ongoing | Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 13891 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | accessdata.fda.gov |
| September 11, 2025 | 97519 | Class I | Ongoing | BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. | accessdata.fda.gov |
| July 10, 2025 | 97245 | Class III | Ongoing | Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/, BD PYXIS MEDBANK MINI 4HM/, BD PYXIS MEDBANK MINI 4HH/, BD PYXIS MEDBANK MINI 3HH-1HM/, BD PYXIS MEDBANK MINI 3HH-1FG/, BD PYXIS MEDBANK MINI 2HM-1FM/, BD PYXIS MEDBANK MI | Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow. | accessdata.fda.gov |
| July 8, 2025 | 97067 | Class I | Ongoing | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. | accessdata.fda.gov |
| May 8, 2025 | 96585 | Class II | Ongoing | Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesi | During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; | accessdata.fda.gov |
| May 8, 2025 | 96477 | Class II | Ongoing | BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyx | Antivirus software was not consistently installed on impacted devices during the implementation process. | accessdata.fda.gov |
| March 11, 2025 | 96564 | Class II | Ongoing | BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM,; MINI 1HH-1FH-1HM,; MINI 1HH-1HM-1FM,; MINI 2FH, 138902-01; MINI 2FH,; MINI 2FM,; MINI 2HH-1FH,; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM,; MINI 2HH-1FM | Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead | accessdata.fda.gov |
| March 11, 2025 | 96557 | Class II | Ongoing | BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorize | Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose o | accessdata.fda.gov |
| March 11, 2025 | 96310 | Class II | Ongoing | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PY | Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for pati | accessdata.fda.gov |
| February 18, 2025 | 96323 | Class I | Ongoing | BD Alaris Systems Manager, REF 9601 Infusion Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). | accessdata.fda.gov |
| February 6, 2025 | 96202 | Class II | Ongoing | BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII | Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, a | accessdata.fda.gov |
| January 23, 2025 | 96069 | Class II | Ongoing | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal | Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open. | accessdata.fda.gov |
| January 23, 2025 | 96004 | Class II | Ongoing | BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authori | Due to fingerprint scanner failing resulting in the scanner heating up. | accessdata.fda.gov |
| January 10, 2025 | 96150 | Class II | Ongoing | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides. | Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions. | accessdata.fda.gov |
| January 8, 2025 | 96124 | Class II | Ongoing | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS ME | Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. | accessdata.fda.gov |
| January 8, 2025 | 96056 | Class II | Ongoing | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation. | accessdata.fda.gov |
| January 8, 2025 | 96055 | Class II | Ongoing | (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00 | Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues | accessdata.fda.gov |
| November 14, 2024 | 95643 | Class II | Ongoing | BD Pyxis MedStation ES, REF: 323 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout. | accessdata.fda.gov |
| August 15, 2024 | 94937 | Class II | Ongoing | Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. | accessdata.fda.gov |
| July 9, 2024 | 95070 | Class II | Ongoing | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Due to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label. | accessdata.fda.gov |
| June 24, 2024 | 94947 | Class II | Ongoing | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: containing software version 3.9.1.9 | Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label. | accessdata.fda.gov |
| May 21, 2024 | 94718 | Class II | Ongoing | BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units | Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. | accessdata.fda.gov |
| May 13, 2024 | 94720 | Class II | Ongoing | BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/, MEDBANK MINI 1FH-2HH MEDPASS/, MEDBANK MINI 1HH-1FH-1HM/, MEDBANK MINI 1HH-1HM-1FM/, MEDBANK MINI 1HH-3HM/, MEDBANK MINI 2FH/, MEDBANK MINI 2FM/, MEDBANK MINI 2HH-1FH/, MEDBANK | Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to pe | accessdata.fda.gov |
| May 2, 2024 | 94699 | Class II | Ongoing | BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wirel | If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication. | accessdata.fda.gov |
| April 15, 2024 | 94527 | Class II | Ongoing | BD Pyxis MedStation ES, REF: 323, Medication Cabinet | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. | accessdata.fda.gov |
| February 23, 2024 | 96041 | Class II | Ongoing | BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider. | Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications. | accessdata.fda.gov |
| February 1, 2024 | 93932 | Class II | Ongoing | BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352 | Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss. | accessdata.fda.gov |
| October 5, 2023 | 96029 | Class II | Ongoing | MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2H | If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal. | accessdata.fda.gov |
| September 15, 2023 | 93106 | Class I | Ongoing | BD Alaris PCU REF 8015 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. | accessdata.fda.gov |
| September 6, 2023 | 93016 | Class II | Ongoing | BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 13 | When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO, which could result in diversion of controlled substances | accessdata.fda.gov |
| August 18, 2023 | 92967 | Class II | Ongoing | BD Pyxis MedBank MedPass Software, REF: 139088-01 | After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration. | accessdata.fda.gov |
| May 22, 2023 | 92404 | Class II | Ongoing | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF:,,,,,,,,,; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 1 | Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock. | accessdata.fda.gov |
| April 5, 2023 | 96002 | Class II | Ongoing | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 | Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be f | accessdata.fda.gov |
| April 5, 2023 | 92061 | Class II | Ongoing | BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop | Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect d | accessdata.fda.gov |
| February 14, 2023 | 96053 | Class II | Ongoing | BD Pyxis MedStation ES (Med ES Main), REF 323 | Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out | accessdata.fda.gov |
| February 14, 2023 | 96020 | Class II | Ongoing | BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and | Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication. | accessdata.fda.gov |
| February 14, 2023 | 91341 | Class II | Ongoing | BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2. | Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications. | accessdata.fda.gov |
| January 24, 2023 | 91582 | Class II | Ongoing | Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 | Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infu | accessdata.fda.gov |
| December 12, 2022 | 91099 | Class II | Ongoing | BD Pyxis MedBank System - Product Label/labeling pending | Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm. | accessdata.fda.gov |
| May 24, 2022 | 90600 | Class II | Ongoing | BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with Matrix Drawers include:. CUBEX MedFlex operating with Windows 7. MedBank 200 Main operating with Windows 7. MedBank 500 Main operating with Windows | The automated dispensing cabinet software update included a.dll file that is not compatible with MedBank Cabinet stations with MedCart Matrix drawers. The cabinet system will stop functioning (Matrix drawers will stop opening in the MedBank Application) leading to delay in access to medications or supplies needed in residential or procedural care facilities. | accessdata.fda.gov |
| March 3, 2021 | 87387 | Class I | Ongoing | BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439. | Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in | accessdata.fda.gov |
| August 4, 2020 | 86005 | Class I | Ongoing | BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alaris PCA Module Model 8120; BD Alaris System; Syringe/PCA Sizer Sensor Replacement Kit, P/N 122278652 | The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in delays in infusion, under-infusion, or over-infusion. | accessdata.fda.gov |
| August 4, 2020 | 85997 | Class II | Ongoing | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 mod | Infusion pump component defect may result in interruption of patient monitoring | accessdata.fda.gov |
| August 4, 2020 | 85962 | Class I | Ongoing | BD Alaris System PC Unit Model 8100 (Pump Module) and Pump Module Door Assembly Replacement Kits (P/N 49000239, 49000346, 49000438, 49000439) infusion pump. | Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations. | accessdata.fda.gov |
| August 4, 2020 | 85900 | Class I | Ongoing | Alaris System PC Unit Model 8015 | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion, interruption of infusion, or inability to titrate medication. For high-risk patient populations who are receiving life-sustaining infusions, delays in an infusion or interruption can cause serious inju | accessdata.fda.gov |
| June 30, 2020 | 85954 | Class I | Terminated | Alaris Pump Module Model 8100 | Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, fre | accessdata.fda.gov |
| June 30, 2020 | 85919 | Class II | Ongoing | Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to ent | LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim. | accessdata.fda.gov |
| June 30, 2020 | 85915 | Class I | Terminated | Alaris System PC Unit Model 8000 modular infusion pump and monitoring system | If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring. | accessdata.fda.gov |
| June 30, 2020 | 85691 | Class I | Terminated | Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring. | accessdata.fda.gov |
| February 4, 2020 | 84579 | Class I | Ongoing | CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518) | 1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations b | accessdata.fda.gov |
| July 1, 2019 | 83296 | Class II | Terminated | Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 | Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 | accessdata.fda.gov |
| April 20, 2018 | 80956 | Class II | Terminated | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FI | Complaints where users were unable to prime the administration set. | accessdata.fda.gov |
| April 13, 2018 | 82143 | Class I | Terminated | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between A | The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interrup | accessdata.fda.gov |
| November 17, 2017 | 78588 | Class II | Terminated | Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medi | The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. | accessdata.fda.gov |
| November 6, 2017 | 80093 | Class II | Terminated | Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These m | Reports of incorrect priming volume due to manufacturing with incorrect tubing. | accessdata.fda.gov |
| August 9, 2017 | 77987 | Class II | Ongoing | Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel K | The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps. | accessdata.fda.gov |
| June 30, 2017 | 77696 | Class II | Terminated | VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into | Punctures in blister packaging that was detected during the packaging process. | accessdata.fda.gov |
| June 12, 2017 | 77279 | Class II | Terminated | Alaris Pump Module model 8100 | There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. | accessdata.fda.gov |
| June 12, 2017 | 77077 | Class II | Terminated | Alaris PC Unit, Model 8015 | BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions. | accessdata.fda.gov |
| February 20, 2017 | 76440 | Class II | Terminated | MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the | CareFusion is recalling the MaxGuard Extension Set due to reports of leaks occurring with the 0.2 micron filter. | accessdata.fda.gov |
| February 20, 2017 | 76439 | Class II | Terminated | MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 | CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing. | accessdata.fda.gov |
| December 2, 2016 | 75466 | Class I | Terminated | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medicat | During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. | accessdata.fda.gov |
| November 17, 2016 | 75013 | Class II | Terminated | SmartSite Add-On Bag Access Device, Model No. 10013365 | CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. | accessdata.fda.gov |
| November 1, 2016 | 75353 | Class II | Terminated | Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. | Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. | accessdata.fda.gov |
| August 8, 2016 | 74508 | Class II | Terminated | Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to | A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another. | accessdata.fda.gov |
| May 12, 2016 | 74142 | Class II | Terminated | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. | A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. | accessdata.fda.gov |
| March 24, 2016 | 73631 | Class II | Terminated | Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. | The Alaris PC units model 8015 may display a system error code due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards. | accessdata.fda.gov |
| February 15, 2016 | 73238 | Class II | Terminated | Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 | CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set. | accessdata.fda.gov |
| February 12, 2016 | 73315 | Class II | Terminated | Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 | CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code ). | accessdata.fda.gov |
| January 15, 2016 | 73093 | Class II | Terminated | Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medicat | Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product. | accessdata.fda.gov |
| November 12, 2015 | 72632 | Class II | Terminated | Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). | CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2. | accessdata.fda.gov |
| November 5, 2015 | 72583 | Class II | Terminated | Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. | accessdata.fda.gov |
| October 9, 2015 | 72384 | Class II | Terminated | SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues. | accessdata.fda.gov |
| July 21, 2015 | 71655 | Class I | Terminated | Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100. | Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached. | accessdata.fda.gov |
| May 13, 2015 | 71081 | Class II | Terminated | Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the A | An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication. | accessdata.fda.gov |
| March 12, 2015 | 70608 | Class II | Terminated | Alaris PC units, Model No. 8015. Infusion pump. | CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue. | accessdata.fda.gov |
| January 13, 2015 | 70260 | Class II | Terminated | SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprise | CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. | accessdata.fda.gov |
| June 17, 2014 | 68608 | Class II | Terminated | SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 | CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occlu | accessdata.fda.gov |
| April 23, 2014 | 68066 | Class I | Terminated | Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The | CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. | accessdata.fda.gov |
| March 19, 2014 | 67774 | Class II | Terminated | SmartSite Extension Set, Model No. 20029E, intravascular administration set. | Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port. | accessdata.fda.gov |
| January 22, 2014 | 67346 | Class II | Terminated | SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector al | CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disc | accessdata.fda.gov |
| January 16, 2014 | 67326 | Class II | Terminated | Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230. | CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak. | accessdata.fda.gov |
| December 5, 2013 | 66865 | Class I | Terminated | Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Ala | CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message. | accessdata.fda.gov |
| November 8, 2013 | 66759 | Class II | Terminated | SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or cathete | CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing. | accessdata.fda.gov |
| November 8, 2013 | 66758 | Class II | Terminated | VersaSafe Extension Set, Model No. 21000M-007 | CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male spin collar to operate as intended. | accessdata.fda.gov |
| August 30, 2013 | 66152 | Class II | Terminated | CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is compr | CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years. | accessdata.fda.gov |
| August 30, 2013 | 66151 | Class II | Terminated | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. | accessdata.fda.gov |
| August 30, 2013 | 66150 | Class II | Terminated | SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead. | accessdata.fda.gov |
| June 17, 2013 | 65564 | Class I | Terminated | Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system | CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor. | accessdata.fda.gov |
| June 29, 2012 | 55121 | Class I | Terminated | Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermit | The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011. | accessdata.fda.gov |
| June 15, 2012 | 62642 | Class I | Terminated | Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood product | The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly | accessdata.fda.gov |
| May 25, 2012 | 62007 | Class I | Terminated | Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code() "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen. | accessdata.fda.gov |
| September 13, 2011 | 60904 | Not yet classified | Terminated | Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. | The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely. | accessdata.fda.gov |
| April 20, 2011 | 58576 | Not yet classified | Terminated | MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a | Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component. | accessdata.fda.gov |
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Updated June 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.